Wolters Kluwer Health

Drug News Update

Recent Updates

Mylan Injectables Recall

04-24-2015

Mylan is voluntarily recalling multiple lots of injectable products to the hospital/user level because of the presence of visible particulate matter. The affected lots (click here to see a full list with distribution dates) include gemcitabine, carboplatin, methotrexate, and cytarabine.

Customers can contact Mylan Customer Relations at 1-800-796-9526 or customer.service@mylan.com, Monday through Friday, 8 AM to 5 PM EST.

Bupivacaine Recall

04-24-2015

Hospira is voluntarily recalling 1 lot (38-515-DK, expiration date February 1, 2016, NDC 0409-1162-02) of preservative-free bupivacaine injection, USP, 0.5% (5 mg/mL), 30 mL, to the user level because of one confirmed customer report of visible iron oxide particles in a single-dose, glass vial. The lot was distributed from July 2014 to September 2014.

Customers should discontinue use and distribution and quarantine the product immediately. Hospira will notify its direct customers via a recall letter and arrange for product return to Stericycle. For additional assistance, customers should call Stericycle at 1-866-918-8770, Monday through Friday, 8 AM to 5 PM EST.

Botox Expanded Indication

04-22-2015

The FDA has approved an expanded indication for Allergan’s Botox (onabotulinumtoxinA) injection to decrease the severity of increased muscle tone in thumb flexors (adductor pollicis and flexor pollicis longus). Botox is also indicated for treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis); treatment of severe primary axillary hyperhidrosis that is inadequately managed by topical agents in adults; treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain associated with cervical dystonia; prophylaxis of headaches in adult patients with chronic migraine; treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or who are intolerant of an anticholinergic medication; treatment of strabismus and blepharospasm associated with dystonia in patients 12 years of age and older; treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Botox labeling includes a Boxed Warning regarding the risk of a spread toxin effect and is dispensed with a patient Medication Guide.

Revised Sporanox Boxed Warning

04-21-2015

The FDA has approved a revised Boxed Warning for Janssen’s Sporanox (itraconazole) capsules to include ticagrelor, fesoterodine, telithromycin, and solifenacin as additional drug interactions when coadministered with Sporanox. The Boxed Warning also states Sporanox should not be administered in patients with congestive heart failure. Sporanox capsules are indicated for treatment of pulmonary and extrapulmonary aspergillosis in immunocompromised and nonimmunocompromised patients who are intolerant of or refractory to amphotericin B therapy; treatment of pulmonary and extrapulmonary blastomycosis in immunocompromised and nonimmunocompromised patients; treatment of histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis in immunocompromised and nonimmunocompromised patients; and treatment of onychomycosis of the toenail, with or without fingernail involvement, and onychomycosis of the fingernail caused by dermatophytes (tinea unguium) in nonimmunocompromised patients.

FDA Approves Generic Copaxone Injection

04-17-2015

The FDA has approved Sandoz’s glatiramer acetate 20 mg/1 mL daily injection, the generic version of Copaxone, indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Expanded Indication for Cardizem LA

04-16-2015

The FDA has approved an expanded indication for Valeant Pharmaceuticals’ Cardizem LA (diltiazem hydrochloride) extended-release tablets to include use for the improvement of exercise tolerance in patients with chronic stable angina. Cardizem LA is also approved for the treatment of hypertension.

Corlanor Approved for Heart Failure

04-16-2015

The FDA has approved Amgen’s Corlanor (ivabradine) oral tablets to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction of 35% or less who are in sinus rhythm with a resting heart rate of at least 70 beats per minute who are taking the highest tolerated doses of beta blockers or who have a contraindication to beta-blocker use. Corlanor was approved under the FDA’s accelerated approval program and will be dispensed with a patient Medication Guide.

Baxter IV Solutions Recall

04-10-2015

Baxter is voluntarily recalling multiple lots of IV solutions due to the potential presence of particulate matter, identified as material from a solution transmission system pump. The affected lots (click here to see a full list) were distributed from January 14 to March 5, 2015.

Customers should discontinue use and return the recalled lots to Baxter by calling 1-888-229-0001, Monday through Friday, 7 AM to 6 PM CST. Unaffected lots of product are available for replacement.

Moderiba Expanded Indication

04-07-2015

The FDA has approved an expanded indication for AbbVie’s Moderiba (ribavirin) tablets for the treatment of patients 5 years of age and older with chronic hepatitis C virus (HCV) infection who have compensated liver disease and have not previously been treated with interferon alpha. Moderiba was previously indicated for treatment only in adults with chronic HCV infection. Moderiba labeling includes a Boxed Warning regarding the risk of hemolytic anemia and teratogenic and/or embryocidal effects. Moderiba is dispensed with a patient Medication Guide.

Neupogen Expanded Indication

04-06-2015

The FDA has approved an expanded indication for Amgen’s Neupogen (filgrastim) injection to increase survival in short-term exposure to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). Neupogen is also indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia; to reduce the duration of neutropenia and neutropenia-related clinical sequelae (eg‚ febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and to reduce the incidence and duration of sequelae of severe neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Expanded Indication for Qudexy XR

04-02-2015

The FDA has approved an expanded indication for Qudexy XR (topiramate) extended-release capsules as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Qudexy XR was previously approved for patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Qudexy XR is also indicated as adjunctive therapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.

Jadenu Approved for Chronic Iron Overload

04-01-2015

The FDA has approved Novartis Pharmaceuticals’ Jadenu (deferasirox), a new once-daily oral tablet formulation, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older and for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia syndromes and with a liver iron concentration of at least 5 mg of iron per gram of liver dry weight and serum ferritin greater than 300 mcg/L. Jadenu labeling includes a Boxed Warning regarding the risks of renal and hepatic failure and GI hemorrhage. Jadenu was approved under the FDA’s accelerated approval program.

Expanded Eylea Indication

03-25-2015

The FDA has approved an expanded indication for Regeneron Pharmaceuticals’ Eylea (aflibercept) intravitreal injection to include the treatment of diabetic retinopathy in patients with diabetic macular edema. Eylea is also indicated for the treatment of neovascular (wet) age-related macular degeneration, for the treatment of macular edema following retinal vein occlusion, and for diabetic macular edema.

Anthrasil Approved for Inhalation Anthrax

03-25-2015

The FDA has approved Emergent BioSolutions’ Anthrasil (anthrax immune globulin intravenous [human]) for the treatment of inhalational anthrax in combination with certain antibacterial drugs. Anthrasil will be stored in the US Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.

Updated Labeling for Harvoni and Sovaldi

03-23-2015

The FDA has approved labeling changes to Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) to include postmarketing information regarding serious and life-threatening cases of symptomatic bradycardia, as well as 1 fatal case of cardiac arrest, when coadministered with amiodarone. Harvoni is indicated for the treatment of chronic hepatitis C genotype 1 infection in adults; Sovaldi is indicated for the treatment of genotype 1, 2, 3, or 4 chronic hepatitis C infection in adults in combination with ribavirin or with peginterferon alfa and ribavirin. Bradycardia may occur within hours to days, but has been reported up to 2 weeks after initiating treatment. Administration of amiodarone with Harvoni or Sovaldi is not recommended.

See revised product labeling for additional information.

New Boxed Warning for Feraheme

03-19-2015

The FDA announced a new Boxed Warning for Amag Pharmaceuticals’ Feraheme (ferumoxytol) injection regarding the risk of fatal and serious hypersensitivity reactions, including anaphylaxis. Feraheme is indicated for the treatment of iron deficiency anemia in adults with chronic kidney disease.

Expanded Indication for Kalydeco

03-19-2015

The FDA has approved an expanded indication for Kalydeco (ivacaftor) tablets and granules to treat cystic fibrosis in patients 2 years and older who have a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation in the cystic fibrosis transmembrane conductance regulator gene. Kalydeco was previously approved for patients 6 years and older.

Cholbam Approved for Bile Acid Synthesis Disorders

03-18-2015

The FDA has approved Asklepion’s Cholbam (cholic acid) capsules for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Cholbam was approved under a “rare pediatric disease” priority review program.

Saphris Expanded Indication

03-17-2015

The FDA has approved an expanded indication for Actavis’ Saphris (asenapine) sublingual tablets as monotherapy for short-term treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. Saphris was previously indicated for this disorder in adult patients only.

Lactated Ringer’s Irrigation Recall

03-12-2015

Hospira is voluntarily recalling 1 lot (40-008-JT, expiration date April 1, 2016, NDC 0409-7828-08) of lactated Ringer’s irrigation 3,000 mL to the user level due to a confirmed customer report of dark, fibrous particulate floating in the solution of the primary container. The particulate was confirmed to be the nontoxic, noninvasive mold Aspergillus kanagawaensis.

Customers with existing inventory should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via recall letter and is arranging for affected product to be returned to Stericycle. For additional assistance, call Stericycle at 1-877-907-7037, Monday through Friday, 8 AM to 5 PM EST.

Treanda Label Changes

03-11-2015

The FDA is warning health care providers not to use Teva’s Treanda solution for injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). N, N-dimethylacetamide, an ingredient in Treanda solution for injection, is incompatible with polycarbonate or ABS and causes the device to dissolve. The FDA also recommends that only a polypropylene syringe (translucent in appearance) with a metal needle and polypropylene hub be used to withdraw and transfer Treanda solution for injection. These restrictions do not apply to Treanda lyophilized powder for injection. Therefore, solutions reconstituted from the lyophilized powder should not be mixed with the solution formulation. The FDA is requiring label changes for both the solution and powder formulations to reflect safe preparation information. Treanda is indicated for the treatment of chronic lymphocytic leukemia and non-Hodgkin lymphoma.

Further information can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437626.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Unituxin Approved to Treat Neuroblastoma

03-11-2015

The FDA has approved United Therapeutics’ Unituxin (dinutuximab) injection indicated, in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid, for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Unituxin labeling includes a Boxed Warning regarding the risks of infusion reactions and neuropathy.

Chantix Label Changes

03-09-2015

The FDA has announced labeling changes for Pfizer’s Chantix (varenicline) to include a warning that its use can change the way people react to alcohol. Rare accounts of seizures in patients taking Chantix have also been reported. Patients should decrease the amount of alcohol they drink until they know how Chantix affects their alcohol tolerance. Patients who have a seizure while taking Chantix should discontinue therapy and seek medical care immediately. Chantix is indicated as an aid to smoking cessation treatment and is approved with a Boxed Warning regarding serious neuropsychiatric events. It is dispensed with a patient Medication Guide.

Further information can be found online.

Magnesium Sulfate Recall

03-09-2015

Hospira is voluntarily recalling 1 lot (42-120-JT, expiration date December 1, 2015, NDC 0409-6727-23) of magnesium sulfate 10 mg/mL in dextrose 5% injection to the user level due to confirmed customer reports of an incorrect barcode on primary bag labeling. The barcode on the overwrap is correct, but the primary container barcode may be mislabeled as heparin sodium 2,000 USP units/1,000 mL in sodium chloride 0.9% injection. The lot was distributed nationwide from October 2014 through January 2015.

Customers with existing inventory should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and is arranging for product return to Stericycle. For additional assistance, call Stericycle at 1-866-382-9260, Monday through Friday 8 AM to 5 PM EST.

Cresemba Approved for Fungal Infections

03-09-2015

The FDA has approved Astellas Pharmaceuticals’ Cresemba (isavuconazonium sulfate) capsules and injection for the treatment of invasive aspergillosis and invasive mucormycosis in patients 18 years and older. Cresemba is the sixth antibacterial or antifungal drug product designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval, making it eligible for priority review to treat serious or life-threatening infections.

New Boxed Warning for Codeine-Containing Products

03-06-2015

The FDA announced a new Boxed Warning for codeine-containing products regarding the risks associated with codeine use as postoperative analgesia in children following tonsillectomy and/or adenoidectomy. The use of codeine in children following these procedures will now also be contraindicated. Health care providers should prescribe an alternate analgesic for postoperative pain control in children undergoing tonsillectomy and/or adenoidectomy. For management of other types of pain in children, codeine should only be used if the benefits are anticipated to outweigh the risks. Parents and caregivers observing unusual sleepiness, confusion, or difficult or noisy breathing in their child should stop giving codeine and seek medical attention immediately, as these may be signs of overdose.

Sodium Chloride 0.9% Injection Recall

03-06-2015

Hospira is voluntarily recalling 1 lot (45-110-C6, expiration date March 1, 2016, NDC 0409-7983-25) of sodium chloride 0.9% injection, 250 mL VisIV flex container to the user level due to 1 confirmed report of human hair in a single unit. The lot was distributed nationwide from December 2014 through January 2015.

Customers with existing inventory should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and is arranging for product return to Stericycle. For additional assistance, call Stericycle at 1-888-714-5079, Monday through Friday 8 AM to 5 PM EST.

Zarxio Approved

03-06-2015

The FDA has approved Sandoz’s Zarxio (filgrastim-sndz), a biosimilar product, approved for treatment in patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

Opdivo Expanded Indication

03-05-2015

The FDA has approved an expanded indication for Bristol-Myers Squibb’s Opdivo (nivolumab) injection to include treatment of metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo for squamous NSCLC was reviewed under the FDA’s priority review program. Opdivo is also approved for the treatment of unresectable or metastatic melanoma and disease progression following ipilimumab and (if BRAF V600 mutation positive) a BRAF inhibitor. Opdivo is dispensed with a patient Medication Guide.

Label Warnings Prohibit Multidose Diabetes Pen Device Sharing

03-04-2015

To reduce the serious risk of infection, the FDA is requiring additional label warnings prohibiting sharing of multidose diabetes pen devices intended for single patient use only. Multidose pens and packaging must now include a warning label stating “For single patient use only.”

Avycaz Approved for Infection

02-26-2015

The FDA has approved Forest Pharmaceuticals’ Avycaz (ceftazidime/avibactam) injection for patients 18 years and older in combination with metronidazole for the treatment of complicated intra-abdominal infections, and as monotherapy for the treatment of complicated urinary tract infections, including pyelonephritis.

Avycaz is the fifth antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval, making it eligible for priority review to treat serious or life-threatening infections.

FDA Approves Toujeo for Diabetes

02-26-2015

The FDA has approved Sanofi’s Toujeo (insulin glargine [rDNA origin]) subcutaneous injection as a once-daily, long-acting basal insulin to improve glycemic control in adults with types 1 and 2 diabetes. Toujeo is expected to be available at the beginning of the second quarter in 2015.

Atracurium Besylate Injection Recall

02-25-2015

Sagent Pharmaceuticals is voluntarily recalling 2 lots (VATA012, VATA015) of atracurium besylate injection 50 mg/mL single-dose vials and 4 lots (VATB012, VATB013, VATB014, VATB017) of atracurium besylate injection 100 mg/10 mL multidose vials to the user level due to FDA observations pertaining to aseptic and good manufacturing practices at the manufacturer’s site that could potentially impact product sterility. The products were manufactured by Emcure Pharmaceuticals and distributed by Sagent Pharmaceuticals to hospitals, wholesalers, and distributors nationwide from February 2014 through February 2015.

Customers should examine their inventory immediately and quarantine, discontinue distribution of, and return the affected lots. For more information, visit www.Sagentpharma.com or call the customer call center at 1-866-625-1618, Monday through Friday, 8 AM to 7 PM CST.

Dymista Expanded Indication

02-25-2015

The FDA has approved an expanded indication for Meda Pharmaceuticals’ Dymista (azelastine hydrochloride/fluticasone propionate) nasal spray to include the relief of symptoms of seasonal allergic rhinitis in patients 6 years and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief. Dymista was previously approved in patients 12 years and older.

Astepro Expanded Indication

02-25-2015

The FDA has approved an expanded indication for Meda Pharmaceuticals’ Astepro (azelastine hydrochloride) nasal spray to include the relief of symptoms of seasonal allergic rhinitis in patients 2 years and older and relief of symptoms of perennial allergic rhinitis in patients 6 months and older. Astepro was previously approved for relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 6 years and older.

Farydak Approved to Treat Multiple Myeloma

02-24-2015

The FDA has approved Novartis’ Farydak (panobinostat) capsules, in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least two prior regimens. Farydak labeling includes a Boxed Warning stating that severe diarrhea and severe and fatal cardiac ischemic events, severe arrhythmias, and electrocardiogram changes have occurred. Farydak was approved under the FDA’s accelerated approval program with a Risk Evaluation and Mitigation Strategy (REMS). It will be dispensed with a patient Medication Guide.

Banzel Expanded Indication

02-17-2015

The FDA has approved an expanded indication for Eisai’s Banzel (rufinamide) tablet and suspension to include the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 year and older. Banzel was previously approved in patients 4 years and older and is dispensed with a patient Medication Guide.

Expanded Indication for Cipro

02-13-2015

The FDA has approved an expanded indication for Bayer’s Cipro (ciprofloxacin) tablets to include the treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis and prophylaxis for plague in adults and pediatric patients. Cipro labeling information includes a Boxed Warning regarding an increased risk of tendonitis and tendon rupture, and exacerbation of muscle weakness in patients with myasthenia gravis. Cipro is dispensed with a patient Medication Guide.

Lenvima Approved to Treat Thyroid Cancer

02-13-2015

The FDA has approved Eisai’s Lenvima (lenvatinib) capsules for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima was approved under the FDA’s accelerated approval program.

Ketorolac Tromethamine Injection Recall

02-11-2015

Hospira is voluntarily recalling multiple lots of ketorolac tromethamine injection in the US and Singapore due to a customer report of visible, floating particulate in glass fliptop vials, identified as calcium-ketorolac crystals. The lots were distributed from February 2013 to December 2014 in the U S and from January 2014 to July 2014 in Singapore.

Customers and health care providers should quarantine, discontinue distribution of, and return the recalled lots. For more information, call Stericycle at 1-888-345-4680, Monday through Friday, 8 AM to 5 PM EST.

For a complete list of recalled products see: http://www.fda.gov/Safety/Recalls/ucm433857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Expanded Indication for Lucentis

02-09-2015

The FDA has approved an expanded indication for Genentech’s Lucentis (ranibizumab) injection to include the treatment of diabetic retinopathy, including proliferative and nonproliferative diabetic retinopathy, in patients with diabetic macular edema (DME). Lucentis is also approved for the treatment of DME, neovascular (wet) age-related macular degeneration, and macular edema following retinal vein occlusion.

Ibrance Approved for Advanced Breast Cancer

02-04-2015

The FDA has approved Pfizer’s Ibrance (palbociclib) capsules, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Ibrance was approved under the FDA’s accelerated approval program.

Zortress Label Changes

02-03-2015

The FDA has approved label changes for Novartis’ Zortress (everolimus) tablets regarding dose adjustment for subtherapeutic and supratherapeutic trough concentrations. Zortress is indicated for prophylaxis of organ rejection in adult kidney and liver transplantation. Zortress labeling includes a Boxed Warning regarding increased susceptibility to infection and possible development of malignancies, as well as increased incidence of kidney graft thrombosis, nephrotoxicity (with concomitant cyclosporine), and increased mortality in heart transplantation, and it is dispensed with a patient Medication Guide.

Prezcobix Approved for HIV-1 Infection

02-02-2015

The FDA has approved Janssen’s Prezcobix (darunavir 800 mg/cobicistat 150 mg) once-daily oral tablets, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults with no darunavir resistance–associated substitutions.

Kaletra Label Changes

02-02-2015

The FDA has approved label changes for AbbVie’s Kaletra (lopinavir/ritonavir) oral solution and tablets pertaining to appropriate use and dosing information in pregnant patients. Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older.

Vyvanse Approved for Binge Eating Disorder

02-02-2015

The FDA has approved an expanded indication for Shire’s Vyvanse (lisdexamfetamine dimesylate) once-daily capsules to include the treatment of moderate to severe binge eating disorder in adults. Vyvanse is also indicated for the treatment of attention deficit hyperactivity disorder. Vyvanse labeling includes a Boxed Warning regarding the potential for abuse and dependence and it is dispensed with a patient Medication Guide.

Evotaz Approved for HIV-1 Infection

02-02-2015

The FDA has approved Bristol-Myers Squibb’s Evotaz (atazanavir 300 mg/cobicistat 150 mg) once-daily oral tablets, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults.

Expanded Indication for Imbruvica

01-29-2015

The FDA has approved an expanded indication for Pharmacyclics’ Imbruvica (ibrutinib) capsules to include the treatment of Waldenström macroglobulinemia. Imbruvica is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 prior therapy; treatment of CLL patients with 17p deletion; and treatment of mantle cell lymphoma in patients who have received at least 1 prior therapy.

FDA Approves Generic Nexium

01-27-2015

The FDA has approved Ivax Pharmaceuticals’ esomeprazole magnesium 20 and 40 mg delayed-release capsules, the generic equivalent to Nexium, indicated for the treatment of gastroesophageal reflux disease in adults and children 1 year and older. This generic will be dispensed with a patient Medication Guide.

Natpara Approved for Hypocalcemia in Hypoparathyroidism

01-26-2015

The FDA has approved NPS Pharmaceuticals’ Natpara (parathyroid hormone) injection as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara prescribing information includes a Boxed Warning regarding the risk of osteosarcoma. Natpara will only be available through a restricted program under a Risk Evaluation and Mitigation Strategy and will be dispensed with a patient Medication Guide.

Prestalia Approved for Hypertension

01-26-2015

The FDA has approved Symplmed’s Prestalia (perindopril arginine/amlodipine) oral tablets for the treatment of patients whose hypertension is not adequately controlled with monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Prestalia labeling carries a Boxed Warning regarding the risk of fetal toxicity.

Bexsero Approved for Serogroup B Meningococcal Disease

01-26-2015

The FDA has approved Novartis Vaccines and Diagnostics’ Bexsero (meningococcal group B) vaccine for the active immunization of children and adults 10 to 25 years of age against invasive meningococcal disease caused by Neisseria meningitidis serogroup B. Bexsero, the second vaccine indicated for the prevention of invasive meningococcal disease, was approved under the FDA’s accelerated approval program. Pfizer’s Trumenba vaccine was approved in October 2014.

Hospira Sodium Chloride Injection Recall

01-23-2015

Hospira is voluntarily recalling 1 lot (44-002-JT, expiration date August 1, 2016) of 0.9% sodium chloride injection, USP, 250 mL to the user level due to particulate matter, identified as a human hair, found in a single unit. This lot was distributed from September 2014 through November 2014. Product from the recalled lot should not be used and Hospira will provide allocation credits and replace the product for contracted customers.

For additional assistance, call Stericycle at 1-877-877-0164, Monday through Friday, 8 AM to 5 PM EST.

Cosentyx Approved for Plaque Psoriasis

01-22-2015

The FDA has approved Novartis Pharmaceuticals’ Cosentyx (secukinumab) subcutaneous injection for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Cosentyx will be dispensed with a Medication Guide.

Halaven Label Changes

01-16-2015

The FDA has approved label changes specifying new dosage recommendations for Eisai’s Halaven (eribulin mesylate) injection. New dosage information states that the recommended dose in patients with moderate or severe renal impairment (creatinine clearance 15 to 49 mL/min) is 1.1 mg/m2 administered over 2 to 5 minutes on days 1 and 8 of a 21-day cycle. Halaven is indicated for treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease.

Aplenzin Label Changes

01-13-2015

The FDA has approved label changes specifying new dosage recommendations for Valeant’s Aplenzin (bupropion hydrobromide) tablets stating that at least 14 days should elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) intended to treat depression and initiation of Aplenzin. Conversely, at least 14 days should be allowed after stopping Aplenzin before starting an MAOI antidepressant. New dosage information also states that Aplenzin should not be started in patients being treated with a reversible MAOI such as linezolid or IV methylene blue. Aplenzin is indicated for the treatment of major depressive disorder and seasonal affective disorder. Aplenzin labeling includes a Boxed Warning regarding suicidal thoughts and behaviors, as well as neuropsychiatric reactions, and is dispensed with a patient Medication Guide.

Duopa Approved for Advanced Parkinson Disease

01-12-2015

The FDA has approved AbbVie’s Duopa (carbidopa/levodopa) enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson disease. Duopa will be administered using a small, portable infusion pump that delivers the drug directly into the small intestine for 16 continuous hours via a procedurally placed tube. Duopa will be dispensed with a Medication Guide.

Anticoagulant Drug Savaysa Approved

01-09-2015

The FDA has approved Daiichi Sankyo’s Savaysa (edoxaban) once-daily tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Savaysa has also been approved to treat deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial therapy with a parenteral anticoagulant. Savaysa labeling includes a Boxed Warning regarding reduced efficacy in nonvalvular atrial fibrillation patients with a creatinine clearance greater than 95 mL per minute, the increased risk of ischemic events with premature Savaysa discontinuation, and the risk of spinal/epidural hematoma. Savaysa will be dispensed with a patient Medication Guide and is expected to be commercially available in the US in February 2015.

Expanded Indication for Natroba

01-08-2015

The FDA has approved an expanded indication for Parapro’s Natroba (spinosad) topical suspension to include the treatment of head lice infestations in patients 6 months of age and older. Natroba was previously indicated for the treatment of head lice infestations in patients 4 years of age and older.

FDA Approves Generic Zyvox Injection

01-08-2015

The FDA has approved Teva’s linezolid injection solution, the generic equivalent to Zyvox, indicated in adults and children for the treatment of community-acquired pneumonia, complicated skin and skin structure infections, nonsocial pneumonia, uncomplicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections.

Gadavist Expanded Indication

01-06-2015

The FDA has approved an expanded indication for Bayer’s Gadavist (gadobutrol) injection to include use in diagnostic magnetic resonance imaging (MRI) in adults and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the CNS. Gadavist was previously indicated for this use in adults and children 2 years and older. Gadavist is also indicated for use with MRI to assess the presence and extent of malignant breast disease and includes a Boxed Warning regarding the risk of nephrogenic systemic fibrosis.

Expanded Taclonex Indication

01-05-2015

The FDA has approved an expanded indication for Leo Pharma’s Taclonex (calcipotriene/betamethasone dipropionate) topical suspension to include the treatment of plaque psoriasis of the scalp in patients 12 to 17 years of age. Taclonex is also approved for the treatment of plaque psoriasis of the scalp and body in patients 18 years and older.

Expanded Use of Kalydeco in Cystic Fibrosis

01-05-2015

The FDA has approved an expanded indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor) tablets to include the treatment of cystic fibrosis patients 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kalydeco is also indicated for the treatment of cystic fibrosis patients 6 years and older who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.

Expanded Indication for Aciphex and Aciphex Sprinkle

12-30-2014

The FDA has approved an expanded indication for Eisai’s Aciphex (rabeprazole) delayed-release tablets and Aciphex Sprinkle (rabeprazole) delayed-release capsules to include the short-term treatment of symptomatic treatment of gastroesophageal reflux disease (GERD) in patients 12 years of age and older for up to 8 weeks, as well as for the treatment of GERD in patients 1 to 11 years of age for up to 12 weeks. Aciphex and Aciphex Sprinkle are also indicated for the treatment of adults with duodenal ulcers, erosive and ulcerative GERD, and pathological hypersecretory conditions, as well as for Helicobacter pylori eradication, and is dispensed with a patient Medication Guide.

FDA Approves Namzaric

12-24-2014

The FDA has approved Actavis and Adamas Pharmaceuticals’ Namzaric (fixed-dose combination of memantine hydrochloride extended-release and donepezil hydrochloride) for the treatment of moderate to severe dementia of the Alzheimer type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Actavis expects to launch Namzaric in the US in the second quarter of 2015.

FDA Approves Saxenda

12-24-2014

The FDA has approved Novo Nordisk’s Saxenda (liraglutide [rDNA origin]) injection as a treatment option for long-term weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of at least 30 (obesity) or adults with a BMI of at least 27 (overweight) who have a least 1 weight-related condition such as hypertension, type 2 diabetes, or high cholesterol. Saxenda labeling includes a Boxed Warning stating that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Saxenda but that it is unknown whether Saxenda causes thyroid C-cell tumors in humans. Saxenda is approved with a Risk Evaluation and Mitigation Strategy (REMS).

Mitoxantrone Recall

12-24-2014

Hospira is voluntarily recalling 10 lots of mitoxantrone due to confirmed subpotency and elevated impurity levels. The recall is to the user level; the lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. Hospira initiated an investigation to determine the root cause, which was found, and appropriate implementations of improvements have been initiated for batches manufactured from March 2014.

Anyone with an existing inventory of the recalled lot should stop using and distributing, and quarantine the product immediately. Hospira has notified its direct customers via a recall letter and is arranging for impacted products to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-265-7407, Monday through Friday, 8 AM to 5 PM EST.

Stribild Expanded Indication

12-24-2014

The FDA has approved an expanded indication for Gilead Sciences’ Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) to include the replacement of the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Stribild. Stribild is also indicated for treatment of HIV-1 infection in adults who are antiretroviral treatment-naive. Stribild labeling includes a Boxed Warning regarding reports of lactic acidosis and severe hepatomegaly; it is not approved for the treatment of chronic hepatitis B virus (HBV) infection and safety and efficacy have not been established in patients coinfected with HBV and HIV-1.

Qnasl Expanded Indication

12-24-2014

The FDA has approved an expanded indication for Teva Respiratory’s Qnasl (beclomethasone dipropionate) intranasal aerosol to include the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years and older.

FDA Approves Rapivab

12-23-2014

The FDA has approved BioCryst Pharmaceuticals’ Rapivab (peramivir) injection for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.

FDA Approves Opdivo

12-23-2014

The FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic melanoma that no longer responds to other drugs. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation (BRAF V600), for use after treatment with ipilimumab and a BRAF inhibitor.

FDA Approves Zerbaxa

12-22-2014

The FDA has approved Cubist Pharmaceuticals’ Zerbaxa (ceftolozane/tazobactam) injection for the treatment of complicated intra-abdominal infections in combination with metronidazole, as well as for complicated urinary tract infections, including pyelonephritis.

Viekira Pak Approved to Treat Hepatitis C

12-19-2014

The FDA has approved AbbVie’s Viekira Pak (ombitasvir, paritaprevir, and ritonavir copackaged with dasabuvir) tablets to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis. Viekira Pak was reviewed under the FDA’s priority review program.

Lynparza Approved to Treat Advanced Ovarian Cancer

12-19-2014

The FDA has approved AstraZeneca’s Lynparza (olaparib) capsules for treatment of women with advanced ovarian cancer associated with defective BRCA genes who have been treated with three or more prior lines of chemotherapy. Lynparza was approved under the FDA’s accelerated approval program along with the companion diagnostic test BRACAnalysis CDx that will detect mutations in the BRCA genes.

Xtoro Approved for Swimmer’s Ear

12-18-2014

The FDA has approved Alcon Laboratories’ Xtoro (finafloxacin) otic suspension for the treatment of acute otitis externa, commonly known as swimmer’s ear, caused by Pseudomonas aeruginosa and Staphylococcus aureus.

Abilify Expanded Indication

12-17-2014

The FDA has approved an expanded indication for Otsuka Pharmaceutical’s Abilify (aripiprazole) oral formulations to include the treatment of Tourette disorder. Abilify is also indicated for bipolar I disorder, irritability associated with autistic disorder, major depressive disorder, and schizophrenia. Abilify labeling includes a Boxed Warning regarding increased mortality in elderly patients with dementia-related psychosis and an increased risk of suicidality with antidepressant drugs in children, adolescents, and young adults and is dispensed with a patient Medication Guide.

Somatuline Depot Expanded Indication

12-17-2014

The FDA has approved an expanded indication for Ipsen Biopharmaceuticals’ Somatuline Depot (lanreotide) 120 mg injection to include the treatment of patients with unresectable, well-differentiated or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival. Somatuline Depot 60, 90, and 120 mg injection is also indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

Helixate FS Expanded Indication

12-16-2014

The FDA has approved an expanded indication for CSL Behring’s Helixate FS (antihemophilic factor, recombinant) injection solution to include routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. Helixate FS is also indicated for routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children without preexisting joint damage, control and prevention of bleeding episodes in adults and children with hemophilia A, and surgical prophylaxis in adults and children with hemophilia A. Helixate FS is dispensed with a patient Medication Guide.

Expanded Indication for Cyramza

12-15-2014

The FDA has approved an expanded indication for Eli Lilly’s Cyramza (ramucirumab) injection solution, in combination with docetaxel, to include the treatment of patients with metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy. Cyramza is also indicated for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. Cyramza's labeling includes a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal events.

Lastacaft Label Changes

12-12-2014

The FDA has approved label changes specifying new dosage recommendations for Allergan’s Lastacaft (alcaftadine) ophthalmic solution. New dosage information states that if more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart. Lastacaft is indicated for the prevention of itching associated with allergic conjunctivitis.

Ziprasidone DRESS Warning

12-11-2014

The FDA is warning that ziprasidone (Geodon) is associated with eosinophilia and systemic symptoms (DRESS), a rare but serious skin reaction that can progress to organ involvement. DRESS is characterized by skin rash, systemic symptoms (malaise, fever, lymphedema), organ involvement (liver, kidney, lungs), and abnormal laboratory values (leukocytosis with eosinophilia, atypical lymphocytosis, increases in ALT). A new warning for DRESS has been added to Geodon product labeling. Ziprasidone is indicated for the treatment of bipolar disorder and schizophrenia and includes a Boxed Warning regarding increased mortality in elderly patients with dementia-related psychosis . Further information can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm426391.htm

Gardasil 9 Approved

12-11-2014

The FDA has approved Merck’s Gardasil 9 (human papillomavirus [HPV] 9-valent) vaccine, recombinant, for the prevention of cervical, vulvar, vaginal, and anal cancers caused by 7 types of HPV, as well as for the prevention of genital warts caused by 2 types of HPV. Gardasil 9 is approved for use in females 9 through 26 years of age and males 9 through 15 years of age. Gardasil 9 protects against 5 additional HPV types compared with Gardasil.

FDA Approves Generic Celebrex

12-10-2014

The FDA has approved Actavis, Mylan, and Teva’s celecoxib 50, 100, 200, and 400 mg capsules, the generic equivalent to Celebrex, indicated for the treatment of signs and symptoms of ankylosing spondylitis, osteoarthritis, primary dysmenorrhea, rheumatoid arthritis, and juvenile rheumatoid arthritis in patients 2 years and older, as well as for the management of acute pain in adults. Celebrex carries a Boxed Warning regarding cardiovascular and GI risks.

Dietary Supplements and Risk of Fungal Disease

12-10-2014

The FDA is warning health care providers of the risks associated with the use of dietary supplements containing live bacteria or yeast in immunocompromised patients. A premature infant died after developing GI mucormycosis caused by the mold Rhizopus oryzae following administration of Solgar’s ABC Dophilus Powder as part of an in-hospital course of treatment. The mold was a contaminant in an unopened container of the powder, a dietary supplement formulated to contain 3 species of live bacteria.

The FDA advises health care providers to use dietary supplements containing live bacteria or yeast with caution in immunocompromised patients and encourages health care providers who use dietary supplements containing live bacteria or yeast as drugs (eg, to treat, mitigate, cure, or prevent a disease or condition) to submit an Investigational New Drug Application for review.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm426331.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Expanded Indication for Xgeva

12-08-2014

The FDA has approved an expanded indication for Amgen’s Xgeva (denosumab) solution for subcutaneous injection for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Xgeva is also indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, as well as for treatment of adults and skeletally mature adolescents with giant cell tumor of the bone.

CDC Advisory for 2014-2015 Influenza Season

12-05-2014

Influenza A (H3N2) viruses have been the most frequently reported so far this season in the US and have been detected in almost all states. During past seasons when influenza A (H3N2) viruses were dominant, higher overall and age-specific hospitalization rates and increased mortality were observed, especially among older people, very young children, and people with certain chronic medical conditions, compared with seasons during which influenza A (H1N1) or influenza B viruses were dominant.

Initial data indicate that 52% of the influenza A (H3N2) viruses collected and analyzed in the US from October 1 through November 22, 2014, were antigenically different from the H3N2 vaccine virus. In past seasons when predominant circulating influenza viruses have been antigenically drifted, decreased vaccine effectiveness has been observed. Because of the detection of these drifted viruses, the CDC is emphasizing the importance of using neuraminidase inhibitor antiviral medications, such as Tamiflu (oseltamivir) and Relenza (zanamivir), as adjuncts to vaccination when indicated for treatment and prevention of influenza.

The CDC recommends that all patients 6 months and older who have not yet received an influenza vaccine this season be vaccinated, and that patients with influenza-like illness who are at high risk for influenza complications seek care promptly to determine if treatment with antiviral medications is warranted.

Expanded Indication for Jakafi

12-04-2014

The FDA has approved an expanded indication for Incyte Corporation’s Jakafi (ruxolitinib phosphate) tablets for the treatment of patients with polycythemia vera who have had an inadequate response to, or cannot tolerate, hydroxyurea. Jakafi is also indicated for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.

Blincyto Approved for Lymphoblastic Leukemia

12-04-2014

The FDA has approved Amgen’s Blincyto (blinatumomab) injection for the treatment of patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Blincyto labeling will include a Boxed Warning regarding the risk of cytokine release syndrome and neurological toxicities. Blincyto has been approved under the FDA’s accelerated approval program and includes a Risk Evaluation and Mitigation Strategy (REMS) and patient Medication Guide.

Pregnancy and Lactation Labeling Changes

12-03-2014

The FDA has published a final rule setting standards for how information about using medicine during pregnancy and breast-feeding is presented in the labeling of prescription drugs and biological products. The current product letter categories (A, B, C, D, and X) used to classify the risks of using prescription drugs during pregnancy will be replaced by 3 detailed subsections describing the risks (Pregnancy, Lactation, and Females and Males of Reproductive Potential). The Pregnancy and Lactation subsections will also include three subheadings (“risk summary,” “clinical considerations,” and “data”) that will provide more detailed information. The intent of the new content and formatting requirements is to provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breast-feeding. The new standards will go into effect June 30, 2015.

FDA Approves Generic Exforge HCT

12-03-2014

The FDA has approved Teva Pharmaceuticals’ amlodipine/valsartan/hydrochlorothiazide tablets, the generic equivalent to Exforge HCT, indicated for the treatment of hypertension to lower blood pressure. Exforge HCT carries a Boxed Warning regarding fetal toxicity.

Bosulif Label Changes

12-02-2014

The FDA has approved label changes for Pfizer’s Bosulif (bosutinib) tablets specifying new starting dosage recommendations for patients with renal or hepatic impairment because of the possible risk of renal or hepatic toxicity. Bosulif is indicated for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia with resistance or intolerance to prior therapy. Bosulif is dispensed with a patient Medication Guide.

Expanded Indication for Priftin

12-02-2014

The FDA has approved an expanded indication for Sanofi-Aventis’ Priftin (rifapentine) tablets for the treatment of latent tuberculosis infection caused by Myobacterium tuberculosis in combination with isoniazid in patients 2 years and older who are at high risk of progression to tuberculosis disease. Priftin is also indicated for the treatment of active pulmonary tuberculosis caused by Myobacterium tuberculosis in combination with one or more antituberculosis drugs in patients 12 years and older. Priftin is dispensed with a patient Medication Guide.

Onexton Approved for Comedonal and Inflammatory Acne

11-26-2014

The FDA has approved Valeant Pharmaceuticals’ Onexton (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%) gel for the once-daily treatment of comedonal and inflammatory acne in patients 12 years and older.

Sensipar Label Changes

11-25-2014

The FDA has approved changes to Amgen’s Sensipar (cinacalcet) labeling to include limitations of use. The limitations of use state that Sensipar is not indicated for use in adults with chronic kidney disease who are not on dialysis because of an increased risk of hypocalcemia. New labeling information also revises Sensipar’s indication for treatment of patients with primary hyperparathyroidism. The changes state that Sensipar is indicated for treatment of hypercalcemia in adults with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. Sensipar is also indicated for treatment of parathyroid carcinoma and secondary hyperparathyroidism.

Gabapentin Capsules Recall

11-25-2014

Aurobindo Pharma USA is voluntarily recalling 1 lot (GESB14011-A; expiration date December 2015) of gabapentin capsules, USP 300 mg 100-count bottles due to complaints that the lot has been found to contain some empty capsules. The recall is to the consumer level.

Consumers, distributors, and retailers that have recalled product should stop using, distributing, or dispensing the affected lot and return to place of purchase. Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at 1-732-839-9400, option 2.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424519.htm

Adcetris Label Changes

11-25-2014

The FDA has approved label changes specifying new dosing recommendations for Seattle Genetics’ Adcetris (brentuximab vedotin) injection. The recommended dose for patients with normal and mild renal function or normal hepatic function is 1.8 mg/kg, up to a maximum of 180 mg. Patients with mild hepatic impairment should receive 1.2 mg/kg, up to 120 mg. Avoid use in patients with severe renal impairment and moderate and severe hepatic impairment. Adcetris is for treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma.

Jevtana Label Changes

11-24-2014

The FDA has approved label changes specifying new dosing recommendations for Sanofi-Aventis’ Jevtana (cabazitaxel) injection. New dosing information includes dosage modifications for patients with peripheral neuropathy. In patients with grade 2 peripheral neuropathy, delay treatment until improvement or resolution, then reduce dosage to 20 mg/m2. In patients with grade 3 or higher peripheral neuropathy, discontinue cabazitaxel. New dosing information also states that concomitant drugs that are strong CYP3A inhibitors may increase plasma concentrations of cabazitaxel and coadministration should be avoided; if coadministration cannot be avoided, a 25% reduction in the cabazitaxel dose should be considered. Jevtana is indicated, in combination with prednisone, for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.

Vyvanse Label Changes

11-24-2014

The FDA has approved label changes specifying new dosing recommendations for Shire’s Vyvanse (lisdexamfetamine dimesylate) capsules. New dosing information now includes a 50 mg/day maximum dose for patients with severe renal impairment and a 30 mg/day maximum recommended dose for patients with end stage renal disease. Vyvanse is indicated for the treatment of attention deficit hyperactivity disorder.

Highly Concentrated Potassium Chloride Injection Recall

11-21-2014

Baxter International is voluntarily recalling 1 lot (P319160, expiration date June 30, 2015, NDC 0338-0709-48) of highly concentrated potassium chloride injection 10 mEq per 100 mL due to a complaint of mislabeling of the overpouch. Some containers were incorrectly labeled on the overpouch as “Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL.” The inability to detect this mislabeling may result in the administration of a dose lower than intended, possibly leading to serious, life-threatening adverse reactions in patients prone to severe electrolyte imbalance. The mislabeled products were distributed to customers between June 23, 2014, and October 2, 2014. Product from the recalled lot should not be used and should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7 AM to 6 PM CST.

FDA Approves Hysingla ER, Abuse-Deterrent Hydrocodone

11-20-2014

The FDA has approved Purdue Pharma’s Hysingla ER (hydrocodone bitartrate) abuse-deterrent, extended-release tablets for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Hysingla ER has properties that are expected to reduce abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break, or dissolve, forming a viscous gel not easily prepared for injection. However, abuse through these routes is still possible. Hysingla ER labeling includes a Boxed Warning regarding the risk for addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; and cytochrome P450 3A4 interaction. Hysingla ER will be part of the FDA’s Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) and will be dispensed with a patient Medication Guide.

Expanded Indication for Avastin

11-17-2014

The FDA has approved Genentech’s Avastin (bevacizumab) solution for intravenous infusion for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan in patients who received no more than 2 prior chemotherapy regimens. Avastin is also approved for the treatment of metastatic colorectal cancer, nonsquamous non–small cell lung cancer, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer in combination with other drugs, as well as for the treatment of glioblastoma as a single agent. Avastin labeling includes a Boxed Warning regarding the risk for gastrointestinal perforation, surgery and wound healing complications, and hemorrhage.

Lemtrada Approved for MS

11-17-2014

The FDA has approved Genzyme’s Lemtrada (alemtuzumab) solution for intravenous infusion for the treatment of patients with relapsing forms of multiple sclerosis (MS). Due to its safety profile, Lemtrada should generally be reserved for use in patients who have had an inadequate response to 2 or more drugs indicated for the treatment of MS. Lemtrada labeling includes a Boxed Warning regarding the risk of serious, sometimes fatal autoimmune conditions; serious and life-threatening infusions reactions; and the potential for increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Lemtrada is approved with a Risk Evaluation and Mitigation Strategy (REMS) and is dispensed with a patient Medication Guide.

Invega Sustenna Expanded Indication

11-14-2014

The FDA has approved Janssen Pharmaceuticals’ Invega Sustenna (paliperidone palmitate) injection for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants. Invega Sustenna was previously indicated for treatment of schizophrenia. Invega Sustenna labeling includes a Boxed Warning regarding increased risk of death in elderly patients with dementia-related psychosis and is dispensed with a Patient Medication guide.

FDA Generic Concerta Concerns

11-14-2014

The FDA has changed the therapeutic equivalence rating for two approved generic versions of Janssen’s Concerta (methylphenidate hydrochloride) extended-release tablets from AB to BX, based on concerns that the products may not be therapeutically equivalent to the brand name drug. FDA laboratory tests of the two generics, manufactured by Mallinckrodt Pharmaceuticals and Kudco, have raised concerns that the products may not produce the same therapeutic benefits for some patients as Concerta.

The products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy, or by a pharmacist, for Concerta. The FDA has not identified any serious safety concerns with these two generic products. Patients should not make changes to their treatment except in consultation with their health care professional.

Patients or health care providers with concerns about lack of desired effect during the dosing period should contact the prescribing health care provider to discuss whether a different drug product would be more appropriate.

For more information see http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm

LAIV (FluMist) Ineffective Against H1N1 in Children Aged 2-8 Years (2013-2014)

11-13-2014

Observational data from the US Flu Vaccine Effectiveness Network and 2 other studies conducted during the 2013-2014 flu season have unexpectedly indicated that live attenuated influenza vaccine (LAIV; FluMist) was not effective against the influenza A H1N1 virus when compared with inactivated influenza vaccine (IIV) in children 2 through 8 years of age. However, the Centers for Disease Control and Prevention (CDC) has not changed its recommendations for the preferential use of LAIV in healthy children 2 through 8 years of age this season, while the American Academy of Pediatrics has not expressed a preference for LAIV. The CDC advises that all eligible children 6 months and older should be immunized against influenza as soon as possible. The CDC also reports that early US surveillance shows a predominance of influenza AH3N2 and influenza B viruses for the 2014-2015 season, compared with instances of H1N1.

Vasostrict Approved for Vasodilatory Shock

11-12-2014

The FDA has approved Par Pharmaceutical’s Vasostrict (vasopressin) injection 20 units/mL indicated to increase blood pressure in adults with vasodilatory shock (eg, postcardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

Abstral Label Changes

11-11-2014

The FDA has approved label changes specifying new dosing recommendations for Galena Biopharma’s Abstral (fentanyl) sublingual tablets. Abstral is indicated for the management of breakthrough cancer pain. New dosing information includes revised dosing recommendations for patients converting to Abstral from Actiq.

FDA Approves Generic Valcyte Tablets

11-10-2014

The FDA has approved Endo International’s valganciclovir 450 mg tablets, the generic equivalent to Valcyte, indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant adult patients at high risk; for prevention of CMV disease in kidney and heart transplant pediatric patients 4 months to 16 years of age at high risk; and for the treatment of CMV retinitis in adults with AIDS.

FDA Approves Generic Stromectol Tablets

11-03-2014

The FDA has approved Edenbridge Pharmaceuticals’ ivermectin 3 mg tablets, the generic equivalent to of Stromectol, indicated for the treatment of intestinal (ie, nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis and the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.

Flublok Approved for Adults 18 Years and Older

10-30-2014

The FDA has approved Protein Sciences’ Flublok (recombinant influenza vaccine) solution for injection for use in all adults 18 years and older against disease caused by influenza subtypes A and type B. Flublok was previously only indicated for use in adults 18 to 49 years of age. Unlike other influenza vaccines, Flublok is produced without live influenza virus or eggs. It has 3 times the active ingredient of traditional influenza vaccines and contains no preservatives (thimerosal), antibiotics, or adjuvants.

Trumenba Approved for Serogroup B Meningococcal Disease

10-29-2014

The FDA has approved Pfizer’s Trumenba for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years. Meningococcal vaccines previously approved for use in the US have covered only 4 of the 5 main serogroups of N. meningitidis bacteria that caused meningococcal disease: A, C, Y, and W. Trumenba was approved under the FDA’s accelerated approval program.

Obizur Approved for Acquired Hemophilia A

10-29-2014

The FDA has approved Baxter Healthcare’s Obizur (antihemophilic factor [recombinant], porcine sequence) for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired factor VIII deficiency).

IntraVia Containers Recall

10-27-2014

Baxter International is voluntarily recalling 2 lots of IntraVia containers in the US and Canada due to complaints about particulate matter found inside the fluid path. The affected lots include IntraVia 150 mL capacity, lot UR13D15112, product code 2B8011, distributed to customers between April 26 and June 20, 2013 and IntraVia empty 500 mL capacity, lot UR13K14095, product code 2B8013, distributed to customers between November 27, 2013 and March 10, 2014. Unaffected lot numbers can continue to be used according to the instructions for use.

Recalled products should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-001, Monday through Friday, 7 AM to 6 PM CST. Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, 8 AM to 5 PM CST, or email Baxter at onebaxter@baxter.com.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm420415.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Naproxen Sodium Tablets Recall

10-22-2014

Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand naproxen sodium 220 mg, 15-count (lot FH4102A) due to cartons actually containing ibuprofen 200 mg softgels. The Assured products were distributed nationwide to Dollar Tree and sold via Dollar Tree retail stores and Internet site.

Contract Packing Resources is notifying its distributors/customers directly and arranging for replacement of all recalled products. Customers may return the recalled products to the place of purchase or call 336-252-3422, Monday through Friday, 8 AM to 4 PM EST.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419769.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Lidocaine Hydrochloride Injection 1% Recall

10-20-2014

Hospira is recalling 1 lot (40-316DK, NDC 0409-4279-02, expiration date April 1, 2016) of lidocaine hydrochloride injection 1%, 10 mg/mL, 30 mL single-dose vial due to a confirmed customer report of particulate identified as a human hair embedded in and attached to a pinched area of the stopper in a single unit. The affected lot was distributed nationwide from May 2014 through June 2014.

Customers with existing inventory should stop use and quarantine the product immediately. Hospira is notifying its direct distributors/customers via a recall letter and will arrange for product return to Stericycle. For additional assistance, call Stericycle at 1-877-546-5069, Monday-Friday, 8 AM-5 PM, EST.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419322.htm

New Abuse-Deterrent Embeda Labeling Approved

10-20-2014

The FDA has approved new labeling for Pfizer’s Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules to include a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed. Embeda is part of the FDA’s Extended Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) that requires companies to make educational programs available to health care professionals on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.

Minivelle Expanded Indication

10-17-2014

The FDA has approved Noven Pharmaceuticals’ Minivelle (estradiol) transdermal system for the prevention of postmenopausal osteoporosis. Minivelle was previously indicated only for the treatment of moderate to severe vasomotor symptoms associated with menopause. Minivelle is dispensed with a patient Medication Guide.

Ofev Approved for Idiopathic Pulmonary Fibrosis

10-16-2014

The FDA has approved Boehringer Ingelheim’s Ofev (nintedanib) oral capsules for the treatment of idiopathic pulmonary fibrosis (IPF).

Esbriet Approved for Idiopathic Pulmonary Fibrosis

10-16-2014

The FDA has approved InterMune’s Esbriet (pirfenidone) oral capsules for the treatment of idiopathic pulmonary fibrosis (IPF).

LifeCare Products Recall

10-15-2014

Hospira is voluntarily recalling certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. A single puncture mark through the overwrap and primary container, identified during a reinspection, may result in leakage that is difficult to detect. The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. Customers with affected inventory should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and will arrange for product return to Stericycle. For additional assistance, call Stericycle at 1-844-861-6221, Monday through Friday, 8 AM to 5 PM EST.

Harvoni Approved for Hepatitis C

10-13-2014

The FDA has approved Gilead’s Harvoni (ledipasvir/sofosbuvir) once-daily oral tablet for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection, as well as the first regimen that does not require administration with interferon or ribavirin.

Akynzeo Approved for Chemotherapy-Associated Nausea

10-10-2014

The FDA has approved Eisai’s Akynzeo (netupitant and palonosetron) capsules to treat nausea and vomiting in patients undergoing cancer chemotherapy.

Vancomycin Hydrochloride Injection Recall

10-09-2014

Hospira is voluntarily recalling 1 lot (35-315-DD, NDC 0409-6533-01, expiration date November 1, 2015) of vancomycin hydrochloride for injection, equivalent to vancomycin 1 g sterile powder, because of possible temperature excursions during shipment. Customers with affected inventory should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and will arrange for product return to Stericycle. For additional assistance, call Stericycle at 1-844-861-6215, Monday through Friday, 8 AM to 5 PM EST.

Eylea Expanded Approval

10-08-2014

The FDA has expanded the approval of Regeneron Pharmaceuticals’ Eylea (aflibercept) intravitreal injection to include macular edema following branch retinal vein occlusion. Eylea was previously approved for the treatment of macular edema only following central retinal vein occlusion. Eylea is also indicated for treatment of diabetic macular edema and neovascular (wet) age-related macular degeneration.

Ketorolac Tromethamine Injection Recall

10-07-2014

Sagent Pharmaceuticals is voluntarily recalling 3 lots (MP5021, MP5024, MP5025) of ketorolac tromethamine injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02). The lots were labeled with an incorrect expiration date that was longer than the known stability of the product. The affected lots were distributed to hospitals, wholesalers, and distributors nationwide from September 17, 2014, through October 1, 2014.

Health care professionals should carefully review product labeling and quarantine, discontinue distribution, and return the recalled lots. For more information, call Sagent at 1-866-625-1618 Monday through Friday, 8 AM to 7 PM CST.

Expanded Indication for Humira–JIA

10-03-2014

The FDA has approved AbbVie’s Humira (adalimumab) injection for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients 2 years and older, alone or in combination with methotrexate. Humira was previously approved for JIA in pediatric patients 4 years and older. Humira is also approved for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years and older with moderately to severely active Crohn disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. Humira labeling includes a Boxed Warning concerning the increased risk of developing serious infections as well as lymphoma and other potentially fatal malignancies in patients treated with tumor necrosis factor–blockers. Humira is dispensed with a patient Medication Guide.

Relistor Expanded Indication

10-03-2014

The FDA has approved Salix Pharmaceuticals’ Relistor (methylnaltrexone bromide) injection for the treatment of opioid-induced constipation in adults with chronic noncancer pain. Relistor was previously indicated only for treatment of opioid-induced constipation in patients with advanced illness (receiving palliative care) who have had an inadequate response to conventional laxative therapy. Relistor is dispensed with a patient Medication Guide.

Expanded Boxed Warning for Revlimid

10-03-2014

The FDA has approved an expanded Boxed Warning for Celgene’s Revlimid (lenalidomide) capsules to include an increased risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with Revlimid and dexamethasone therapy, as well as an increased risk of deep vein thrombosis. The Boxed Warning also includes information regarding embryo-fetal toxicity and hematologic toxicity. Revlimid is dispensed with a Risk Evaluation and Mitigation Strategy (REMS) and a patient Medication Guide.

Ozurdex Expanded Indication

10-01-2014

The FDA has approved Allergan’s Ozurdex (dexamethasone intravitreal implant) for the treatment of all patients with diabetic macular edema. Ozurdex was previously indicated for treatment of diabetic macular edema in patients who are pseudophakic or are phakic and scheduled for cataract surgery. Ozurdex is also indicated for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion and treatment of noninfectious uveitis affecting the posterior segment of the eye.

Fosrenol New Doseform

09-30-2014

The FDA has approved Shire’s Fosrenol (lanthanum carbonate) new 750 mg and 1,000 mg oral powder doseform and label changes specifying dosing recommendations for its proper administration. Fosrenol is approved to reduce serum phosphate in patients with end-stage renal disease. Fosrenol is dispensed with a patient Medication Guide.

Tybost Approved to Treat HIV-1 Infection

09-26-2014

The FDA has approved Gilead Sciences’ Tybost (cobicistat) 150 mg tablets, indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection.

Vitekta Approved to Treat HIV-1

09-26-2014

The FDA has approved Gilead Sciences’ Vitekta (elvitegravir) 85 and 150 mg tablets, used in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults.

Expanded Indication for Otezla

09-25-2014

The FDA has approved Celgene’s Otezla (apremilast) oral tablets for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is also indicated for the treatment of adult patients with active psoriatic arthritis.

Expanded Indication for Humira

09-25-2014

The FDA has approved AbbVie’s Humira (adalimumab) injection for the treatment of moderately to severely active Crohn disease in patients 6 years of age and older who have had inadequate response to corticosteroids or immunomodulators. Humira is also approved for juvenile idiopathic arthritis in patients 4 years of age and older and the treatment of ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis in adults. Humira labeling contains a Boxed Warning regarding the increased risk of developing serious infections, lymphoma, and other potentially fatal malignancies that have been reported in patients treated with tumor necrosis factor–blockers. Humira is dispensed with a patient Medication Guide.

Hydrocodone Combination Product Reclassification Allowance

09-24-2014

Although the US Drug Enforcement Agency (DEA) has announced that all hydrocodone combination products will be placed into Schedule II of the Controlled Substances Act (CSA) effective October 6, 2014, the agency is allowing pharmacies to honor hydrocodone combination product refills authorized prior to October 6, 2014, as long as no refills are dispensed after April 8, 2015. No new refills may be authorized after October 6, 2014.

http://online.factsandcomparisons.com/News/NewsArticle.aspx?id=1009714

http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0822.htm

Trulicity Approved to Treat Type 2 Diabetes

09-19-2014

The FDA has approved Eli Lilly’s Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise. Trulicity labeling includes a Boxed Warning regarding the risk of thyroid C-cell tumors. Trulicity has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is dispensed with a patient Medication Guide.

Stendra Label Changes

09-19-2014

The FDA has approved label changes specifying new dosing recommendations for Vivus’ Stendra (avanafil) tablets. Stendra is indicated for the treatment of erectile dysfunction. New dosing information states that 100 and 200 mg Stendra may be taken as early as 15 minutes before sexual activity. The 50 mg tablet should still be taken approximately 30 minutes before sexual activity.

Potassium Chloride Injection Recall

09-18-2014

Baxter International is voluntarily recalling 1 lot (lot #P318220, NDC #0338-0709-48) of potassium chloride 10 mEq/100 mL injection because of a labeling error on the shipping cartons. Shipping cartons labeled for this lot may contain units of gentamicin sulfate 80 mg/100 mL injection. Because the packaging and labeling for these products is similar, there is potential risk for medication error or delay in therapy for patients requiring high concentration potassium chloride. The affected lot of potassium chloride injection was distributed between May 26, 2014, and August 8, 2014.

Health care professionals should carefully review product labeling before administering medication. For more information, call Baxter at 1-800-422-9837, Monday through Friday, 8 AM to 5 PM CST.

FDA Approves Movantik for Opioid-Induced Constipation

09-17-2014

The FDA has approved AstraZeneca’s Movantik (naloxegol, Schedule II) tablets for the treatment of opioid-induced constipation in adult patients with chronic noncancer pain. Movantik will be dispensed with a patient Medication Guide.

Heparin Recall

09-12-2014

Hospira is voluntarily recalling 1 lot (41-046-JT, expiration date November 1, 2015) of heparin sodium 1,000 USP heparin units/500 mL in 0.9% sodium chloride injection, 500 mL, because of the presence of particulate matter confirmed to be human hair. The affected lot was distributed nationwide between June 2014 and August 2014.

Customers should immediately stop use and quarantine all affected product. Hospira will notify its direct distributors/customers via a recall letter and arrange for product return to Stericycle. For more information, call Stericycle at 1-855-201-4337, Monday through Friday, 8 AM to 5 PM EST.

Contrave Approved for Weight Loss

09-11-2014

The FDA has approved Orexigen Therapeutics’ Contrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets for the treatment of long-term weight management in adults with a body mass index (BMI) of 30 or more or in adults with a BMI of 27 or more who have at least 1 weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia. It is meant to be used in conjunction with a reduced-calorie diet and exercise. Contrave labeling includes a Boxed Warning regarding the increased risk of suicidal thoughts and behavior and also states that serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation. It will be dispensed with a patient Medication Guide.

Expanded Indication for Menactra

09-10-2014

The FDA has approved Sanofi Pasteur’s Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) for booster vaccination against meningococcal disease in patients 15 years through 55 years of age. Menactra is also approved for primary active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in patients 9 months to 55 years of age. Menactra vaccine does not prevent Neisseria meningitidis serogroup B disease.

Expanded Indication for Epaned

09-09-2014

The FDA has approved Silvergate Pharmaceuticals’ Epaned (enalapril maleate powder for oral solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunction. Epaned oral solution was previously approved only for treatment of hypertension in patients older than 1 month. Epaned powder for oral solution includes a Boxed Warning concerning pregnancy and potential injury and death to a developing fetus.

New DEA Ruling for Prescription Drug Disposal

09-08-2014

The Drug Enforcement Administration (DEA) has announced a new regulation permitting consumers to return unused medications to authorized collectors, including pharmacies, beginning next month. The decision comes after increasing concern over the rise in abuse rates for prescription drugs. The new regulation covers drugs designated as controlled substances (eg, OxyContin, Adderall, Ativan, etc.), which previously could only be disposed of by patients themselves or surrendered to law enforcement. Patients and their relatives will now also be allowed to mail unused drugs to authorized collectors using packages available at pharmacies and other locations. The program will be voluntary, and pharmacies may choose to register with the DEA to take back controlled substances or to receive them through the mail. The Final Rule will be released tomorrow. See the news release for more information.

Pharmacy Creations Recall

09-08-2014

Pharmacy Creations, a compounding and nutritional pharmacy, has voluntarily recalled 4 product lots following testing results indicating that the lots may not be sterile. The preparations were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014, and June 18, 2014, and were mailed directly to patients and physicians. There are serious health implications associated with the use of contaminated products, which could include development of a life-threatening infection. To date, there have been no reported adverse events associated with the use of the suspected products.

Customers should stop use of recalled products and return them to the place of purchase. Patients should contact their physician or health care provider if they have experienced any problems that may be related to these drug products. Customers with questions related to this recall should contact Pharmacy Creations at 1-858-366-8389, Monday through Friday, 8 AM to 5 PM EST.

Requip Label Changes

09-08-2014

The FDA has approved label changes specifying new dosing recommendations for Requip (ropinirole). Requip is indicated for the treatment of Parkinson disease and the treatment of moderate to severe primary restless legs syndrome (RLS). New dosing information recommends a maximum dose of 18 mg/day (Parkinson disease) or 3 mg/day (RLS) for patients with end-stage renal impairment on hemodialysis.

Keytruda Approved for Advanced Melanoma

09-05-2014

The FDA has approved Merck’s Keytruda (pembrolizumab) injection for treatment of patients with advanced or unresectable melanoma who are no longer responding to other therapies. Keytruda is intended for use following treatment with ipilimumab and, in BRAF V600 mutation–positive patients, a BRAF inhibitor. Keytruda was approved under the FDA’s accelerated approval program and will be dispensed with a patient Medication Guide.

Compounded Sterile Preparations Recall

09-03-2014

Martin Avenue Pharmacy is voluntarily recalling all in-date compounded sterile preparations due to observations made during a recent FDA inspection associated with certain quality control procedures that present a risk to sterility assurance. Martin Avenue Pharmacy supplied compounded sterile preparations to health care providers and individual patients by prescription until August 20, 2014, in the following states: IL, WI, OH, MI, FL, AL, and TX (see http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM412523.pdf for a list of all affected products.

Consumers or health care providers with questions related to this recall may contact Marvin Avenue Pharmacy by phone 1-630-355-6400 or toll free 1-888-355-6492, Monday-Friday, 9 AM to 7 PM CST, or by email at info@martinavenue.com

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm412493.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#

Vimpat Expanded Indication

09-03-2014

The FDA has approved UCB’s Vimpat (lacosamide) in patients 17 years and older with partial-onset seizures as monotherapy or adjunctive therapy. Vimpat was previously approved only for adjunctive therapy in patients with partial-onset seizures and is dispensed with a patient Medication Guide.

Elelyso Expanded Indication and Label Changes

08-29-2014

The FDA has approved Pfizer’s Elelyso (taliglucerase alfa) injection for long-term enzyme replacement therapy in adult and pediatric patients with a confirmed diagnosis of type 1 Gaucher disease. Elelyso was previously only approved for treatment in adults. The recommended dosage for treatment-naïve adult and pediatric patients 4 years and older is 60 units per kilogram of body weight administered every other week as a 60- to 120-minute intravenous infusion.

Ryanodex Approved for Malignant Hyperthermia

08-28-2014

The FDA has approved Eagle Pharmaceuticals’ Ryanodex injection, a new formulation of dantrolene sodium based on nanosuspension technology, indicated for the prevention or treatment of malignant hyperthermia. Ryanodex is available as a lyophilized powder in a 250 mg vial and is reconstituted with only 5 mL of sterile water for injection, allowing for faster reconstitution and treatment.

Expanded Indication for Promacta

08-28-2014

The FDA has approved GlaxoSmithKline’s Promacta (eltrombopag) oral tablets for the treatment of severe aplastic anemia in patients who have had an insufficient response to immunosuppressive therapy. Promacta is also indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy, as well as for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Promacta includes a Boxed Warning concerning the risk of hepatic decompensation when used in combination with interferon and ribavirin in patients with hepatitis C and is dispensed with a patient Medication Guide.

Zorvolex Expanded Indication and Label Changes

08-26-2014

The FDA has approved an expanded indication and label changes specifying new dosing recommendations for Iroko Pharmaceuticals’ Zorvolex (diclofenac) capsules. Zorvolex is now approved for the management of osteoarthritis pain and the recommended dosage is 35 mg three times daily. Zorvolex is also indicated for the management of mild to moderate acute pain and includes a Boxed Warning regarding the increased risk of serious cardiovascular and gastrointestinal events.

Expanded Boxed Warning for Zohydro ER

08-22-2014

The FDA has approved an expanded Boxed Warning for Zogenix’s Zohydro ER (hydrocodone bitartrate) to alert health care providers that concomitant use with all cytochrome P450 (CYP-450) 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. The new information also states that discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in hydrocodone plasma concentration and to monitor patients receiving Zohydro ER and any CYP3A4 inhibitor or inducer. Zohydro ER is dispensed with a Patient Medication Guide.

Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II

08-22-2014

The US Drug Enforcement Agency (DEA) announced that hydrocodone combination products will be placed into Schedule II of the Controlled Substances Act (CSA) effective October 6, 2014. All single ingredient hydrocodone products (eg, Zohydro ER) are already in Schedule II of the CSA and are not impacted by this action.

More information is available at: https://www.federalregister.gov/articles/2014/08/22/2014-19922/schedules-of-controlled-substances-rescheduling-of-hydrocodone-combination-products-from-schedule

FDA Approves Arnuity Ellipta for Asthma

08-22-2014

The FDA has approved GlaxoSmithKline’s Arnuity Ellipta (fluticasone furoate inhalation powder) for maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.

FDA Approves Cerdelga for Gaucher Disease Type 1

08-20-2014

The FDA has approved Genzyme’s Cerdelga (eliglustate) capsules for the long-term treatment of adult patients with Gaucher disease type 1 who are cytochrome P450 (CYP-450) 2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers as detected by an FDA-cleared test. Patients who are CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations of the drug to achieve a therapeutic effect. A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined.

Plegridy Approved for Relapsing Forms of Multiple Sclerosis

08-18-2014

The FDA has approved Biogen Idec’s Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis.

Dianeal Low Calcium Recall

08-18-2014

Baxter International is voluntarily recalling 2 lots (C940700 and C940841) of Dianeal Low Calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose 5,000 mL (Ambu-Flex II) at the hospital/user level because of the presence of oxidized stainless steel, garment fiber, and polyvinyl chloride particulate matter identified during the manufacturing process. The affected lots were distributed between May 30, 2014, and July 9, 2014. Intraperitoneal administration of a product with particulate matter may cause local inflammation with foreign body reaction or result in adhesion formation. The particulate matter could potentially serve as a focal point for infection should any preexisting peritonitis exist, and may lead to a fatal outcome.

Affected product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7 AM to 6 PM, CST.

Expanded Indication for Avastin

08-18-2014

The FDA has approved an expanded indication for Genentech’s Avastin (bevacizumab) to include treatment of patients with persistent, recurrent, or late-stage (metastatic) cervical cancer. Avastin is also indicated for the treatment of glioblastoma, metastatic colorectal cancer, metastatic renal cell carcinoma, and nonsquamous non–small cell lung cancer.

Tramadol Designated as Schedule IV Drug

08-14-2014

The US Drug Enforcement Agency (DEA) announced that tramadol has been placed into Schedule IV of the Controlled Substances Act effective August 18, 2014, because of its abuse potential. Abuse of a drug in Schedule IV may lead to limited physical dependence or psychological dependence relative to the drugs in Schedule III. New scheduling applies to all tramadol salts, isomers, and salts of isomers.

Tramadol is a centrally acting opioid analgesic indicated for the treatment of moderate to moderately severe pain in adults and was not previously a scheduled drug. Various formulations are sold under several trade names, including Ultram, Ultram ER, and ConZip.

More information is available at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0702.htm.

Baxter Sodium Chloride 0.9% Injection Recall

08-14-2014

Baxter International is voluntarily recalling 1 lot (C931923, product code 2B1324X) of sodium chloride 0.9% injection, USP 1,000 mL, as a result of particulate matter found near the administration port. The affected lot was distributed in the US between February 27, 2014 and March 1, 2014.

Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7 AM to 6 PM, CST. Customers can call 1-800-422-9837, Monday through Friday, 8 AM to 5 PM, CST, or email onebaxter@baxter.com for more information.

Belsomra Approved for Insomnia

08-14-2014

The FDA has approved Merck, Sharpe & Dohme’s Belsomra (suvorexant) oral tablets for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Belsomra tablets will be available in 5, 10, 15, and 20 mg strengths and should be taken no more than once per night, within 30 minutes of going to bed, with at least 7 hours remaining before waking. The total dose should not exceed 20 mg once daily, and patients taking 20 mg should be cautioned against next-day driving or activities requiring full mental awareness. The FDA has recommended that Belsomra be classified by the US Drug Enforcement Agency (DEA) as a scheduled product and will not be available until the DEA makes a final decision. Belsomra will be dispensed with a patient Medication Guide and is expected to be available in late 2014 or early 2015.

FDA Approves Nutrilipid 20% for Parenteral Nutrition

08-13-2014

The FDA has approved B. Braun Medicals’ Nutrilipid 20% (IV fat emulsion) for parenteral nutrition therapy in adult and pediatric patients. The drug is indicated as a source of calories and essential fatty acids for parenteral nutrition, and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Cubicin Recall - Update

08-08-2014

Cubist Pharmaceuticals has expanded the previous recall of Cubicin (daptomycin) 500 mg in 10 mL single-use vials at the user level to include additional lots because of the potential presence of glass particulate matter in reconstituted vials. Cubicin is indicated for the treatment of complicated skin and skin structure infections, as well as for the treatment of Staphylococcus aureus blood stream infections.

Customers should quarantine all affected products and arrange for return and replacement by contacting Cubist at 855-534-8309, Monday through Friday, 9 AM to 7 PM, EDT.

RegenESlim Supplement Recall

08-08-2014

Regeneca Worldwide, a division of VivaCeuticals Inc, is voluntarily recalling RegenESlim appetite control dietary supplement capsules (lots EX0616R1584 and 11414RE5516) after FDA analysis confirmed the presence of 1,3-dimethylamylamine, methylhexanamine (DMAA). DMAA, also known as geranium extract, is commonly used as a stimulant and preworkout and weight loss ingredient in dietary supplements. The FDA has warned that DMAA is potentially dangerous because it can narrow blood vessels and arteries, causing a rise in blood pressure or other cardiovascular problems.

Consumers with affected RegenESlim product should immediately stop use and return it to the place of purchase. Questions can be directed to Regeneca at 1-949-281-2600 between 9 AM and 6 PM, PDT.

Orbactiv Approved for Skin Infections

08-07-2014

The FDA has approved The Medicines Company’s Orbactiv (oritavancin) intravenous injection for the treatment of adults with acute bacterial skin and skin structure infections caused by certain bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis.

Orbactiv is the third drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval, making it eligible for priority review because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.

Iclusig Label Changes

08-07-2014

The FDA has approved label changes specifying new dosing recommendations for Iclusig (ponatinib). Iclusig is indicated for the treatment of adult patients with Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ALL) for whom no other tyrosine kinase inhibitor therapy is indicated or who are T315I positive, as well as for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) for whom no other tyrosine kinase inhibitor therapy is indicated or who are T315I positive. New dosing information recommends a starting dose of 30 mg once daily for patients with mild, moderate, and severe hepatic impairment (Child-Pugh class A, B, or C). Iclusig labeling includes a Boxed Warning regarding the risk of vascular occlusion, heart failure, and hepatotoxicity, as well as a Risk Evaluation and Mitigation Strategy (REMS), and is dispensed with a patient Medication Guide.

See previous story.

Expanded Indication and Boxed Warning for Lumizyme

08-04-2014

The FDA has approved an expanded indication for Genzyme’s Lumizyme (alglucosidase alfa) to include the treatment of patients with infantile-onset Pompe disease, including patients younger than 8 years. Lumizyme is also approved for late-onset Pompe disease in patients 8 years and older. The Boxed Warning has been revised to include safety information that infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and require additional monitoring. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program has been eliminated.

FDA Approves Jardiance for Type 2 Diabetes

08-01-2014

The FDA has approved Boehringer Ingelheim Pharmaceuticals’ Jardiance (empagliflozin) tablets to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise.

Striverdi Respimat Approved for COPD

08-01-2014

The FDA has approved Boehringer Ingelheim Pharmaceuticals’ Striverdi Respimat (olodaterol) long-term, once-daily inhalation spray 5 mcg to treat patients with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat will be dispensed with a patient Medication Guide.

Expanded Indication for Eylea

07-31-2014

The FDA has approved an expanded indication for Regeneron’s Eylea (aflibercept) injection to include the treatment of diabetic macular edema. Eylea is also indicated for the treatment of neovascular (wet) age-related macular degeneration and for the treatment of macular edema following central retinal vein occlusion.

Lidocaine Hydrochloride Injection 2% Recall

07-30-2014

Hospira is recalling 1 lot (25-550-DD, NDC 0409-2066-05, expiration date January 1, 2015) of lidocaine hydrochloride injection 2%, 20 mg/mL, 5 mL single-dose vial due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate, identified as iron oxide, embedded in the molded glass container. The affected lot was distributed nationwide to distributors/wholesalers, hospitals, and clinics from June 2013 through July 2013.

Customers with existing inventory should stop use and quarantine the product immediately. Hospira is notifying its direct distributors/customers via a recall letter and will arrange for product return to Stericycle. For additional assistance, call Stericycle at 1-855-827-6586, Monday-Friday, 8 AM-5 PM, EST.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm407249.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Expanded Indication for Imbruvica

07-29-2014

The FDA has approved an expanded indication for Pharmacyclics’ Imbruvica (ibrutinib) capsules to include the treatment of patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica is also approved for the treatment of mantle cell lymphoma in patients who have received at least 1 prior therapy and for the treatment of CLL in patients who have received at least 1 prior therapy.

Unique Pharmaceuticals Sterile Drug Products Recall - Update

07-24-2014

The FDA is alerting health care professionals and consumers of a voluntary recall of all nonexpired drug products for sterile use produced by Unique Pharmaceuticals. The recalled products include lot 86513, N-acetyl cysteine 20%, and all other nonexpired, purportedly sterile drug products. Two recent FDA inspections of the Unique Pharmaceuticals facility observed unsanitary conditions, including environmental contamination and poor sterile production processes, that result in a lack of sterility assurance. The products were distributed nationwide, and most of the labels include: Unique Pharmaceuticals, Temple TX USA 76502.

Health care providers should check their medical supplies and quarantine any sterile drug products from Unique Pharmaceuticals.

Abuse-Deterrent Oxycodone Approved

07-24-2014

The FDA has approved Purdue Pharma’s Targiniq ER (oxycodone hydrochloride/naloxone hydrochloride) extended-release tablets for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER has properties that are expected to deter abuse because when crushed and snorted, or crushed, dissolved, and injected, naloxone (frequently used to reverse the effects of opioid overdose) blocks the euphoric effects of oxycodone. However, Targiniq ER can still be abused, including when taken orally, the most common method of oxycodone abuse. Targiniq ER has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is dispensed with a patient Medication Guide.

FDA Approves Zydelig for Blood Cancers

07-23-2014

The FDA has approved Gilead Sciences’ Zydelig (idelalisib) 150 mg tablets to treat patients with 3 types of blood cancers. Zydelig, in combination with Rituxan (rituximab), is indicated for the treatment of patients with relapsed chronic lymphocytic leukemia for whom Rituxan alone would be considered appropriate therapy due to other comorbidities. Zydelig is also approved to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma who have received at least 2 prior systemic therapies and for patients with relapsed small lymphocytic lymphoma who have received at least 2 prior systemic therapies.

Zydelig includes a Boxed Warning regarding fatal and serious toxicities including liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis), and intestinal perforation that can occur in Zydelig-treated patients. Zydelig is also being approved with a Risk Evaluation and Mitigation Strategy (REMS).

Ibuprofen and Oxcarbazepine Tablets Recall

07-22-2014

American Health Packaging is voluntarily recalling 1 lot (142588, expiration date January 2016) of ibuprofen 600 mg tablets and 1 lot (142544, expiration date February 2016) of oxcarbazepine 300 mg tablets due to mislabeled packaging. The ibuprofen tablets were distributed in a hospital unit dose presentation that may contain individual blistered doses labeled as oxcarbazepine tablets 300 mg. The mislabeled inner unit dose blister packaging could result in patients receiving ibuprofen instead of their scheduled dose of oxcarbazepine, indicated for partial seizures in patients with epilepsy. The affected products were distributed nationwide beginning June 20, 2014.

Customers with the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 1-855-419-4608 (7 AM-5 PM, CST) for return instructions. For questions or product complaints related to oxcarbazepine 300 mg tablets or ibuprofen 600 mg tablets, contact American Health Packaging customer service at 1-800-707-4621 (8 AM-4 PM, EST).

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm406124.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Sterile Drug Products Recall - NuVision

07-21-2014

The FDA is alerting health care professionals not to use drugs marketed as “sterile” that were produced by Downing Labs LLC, also known at NuVision Pharmacy, due to possible contamination. FDA investigators inspected NuVision and observed unsanitary conditions that result in a lack of sterility assurance for purportedly sterile drugs. The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in 3 lots of drug products, and inadequate or no investigation of these failures. These products were distributed nationwide, and most of the labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.

Health care providers should check their medical supplies and quarantine any sterile drug products from NuVision.

Baxter IV Solutions Recall

07-18-2014

Baxter International is voluntarily recalling 4 lots (P298190, expiration date August 2014; P308650, expiration date October 2014; P309187, expiration date October 2014; P309476, expiration date October 2014) of sodium chloride and potassium chloride intravenous solutions due to particulate matter in the vials. The affected lots were distributed between February 2013 and June 2014.

Customers with affected lots should stop use; unaffected lots are available for replacement. Recalled products should be returned for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001 (Monday- Friday, 7 AM-6:00 PM, CST). For additional information, call Baxter at 1-800-422-9837 (Monday-Friday, 8 AM-5 PM, CST) or email at onebaxter@baxter.com.

http://www.fda.gov/Safety/Recalls/ucm405469.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA Approves Ruconest for Hereditary Angioedema

07-17-2014

The FDA has approved Pharming Group NV’s Ruconest (C1 esterase inhibitor [recombinant]) powder for injection for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema, a rare and potentially life-threatening genetic disease. Ruconest will be distributed in the US by Salix Pharmaceuticals, which plans to make the drug available later in 2014.

Cleocin Phosphate Label Changes

07-15-2014

The FDA has approved label changes clarifying administration recommendations for Pfizer’s Cleocin Phosphate (clindamycin) injection. The updated labeling emphasizes that clindamycin phosphate for intramuscular administration should be used undiluted and clindamycin phosphate for intravenous administration should be diluted. Cleocin Phosphate is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria and includes a Boxed Warning regarding Clostridium difficile–associated diarrhea.

Lactated Ringer’s and 5% Dextrose Injection Recall

07-11-2014

Hospira has initiated a voluntary nationwide user-level recall of 1 lot (35-118-JT, NDC 0409-7929-09, expiration date November 1, 2015) of Lactated Ringer’s and 5% Dextrose 1,000 mL due to a confirmed customer report of a filamentous-like structured particulate indicative of mold that was identified in the solution of the primary container. Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak.

Customers with existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457, Monday-Friday, 8 AM-5 PM, EST to arrange for product return.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm404667.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Expanded Indication for NovoSeven RT

07-09-2014

The FDA has approved an expanded indication for Novo Nordisk’s NovoSeven RT (coagulation factor VIIa, [recombinant]) to include treatment of bleeding episodes and peri-operative management in adults and children with Glanzmann thrombasthenia refractory to platelet transfusions, with or without antibodies to platelets. NovoSeven RT was previously approved for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to factor VIII or factor IX and in patients with acquired hemophilia; for the prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to factor VIII or factor IX and in patients with acquired hemophilia; for the treatment of bleeding episodes in patients with congenital factor VII deficiency; and for the prevention of bleeding in surgical interventions or invasive procedures in patients with congenital factor VII deficiency, and includes a Boxed Warning regarding serious thrombotic adverse events.

FDA Approves Kerydin for Onychomycosis

07-09-2014

The FDA has approved Anacor Pharmaceutical’s Kerydin (tavaborole) topical solution 5%, an oxaborole antifungal, for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Beleodaq Approved for Peripheral T-Cell Lymphoma

07-03-2014

The FDA has approved Spectrum Pharmaceuticals’ Beleodaq (belinostat) injection for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma. The action was taken under the agency’s accelerated approval program.

Coumadin Injection Recall

07-02-2014

Bristol-Myers Squibb is voluntarily recalling 6 lots (201125, expiration date September 2014; 201126, expiration date November 2014; 201127 expiration date December 2014; 201228, expiration date June 2015; 201229, expiration date July 2015; 201230, expiration date September 2015) of Coumadin (warfarin sodium) for injection 5 mg single-use vials due to visible particulate matter found in a small number of unreleased samples. The affected lots were distributed to hospitals and pharmacies from November 2011 through January 2014. Coumadin for injection was discontinued in early April 2014. The oral tablets are not affected by the recall.

Anyone that has the affected lots should stop use and distribution and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for return of remaining stock. For additional information, call Bristol-Myers Squibb Customer Information Center at 1-800-332-2056.

http://www.fda.gov/Safety/Recalls/ucm403501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Expanded Indication for Ozurdex

07-02-2014

The FDA has approved an expanded indication for Allergan’s Ozurdex (dexamethasone intravitreal implant) to include the treatment of diabetic macular edema in patients who are pseudophakic or are phakic and scheduled for cataract surgery. Ozurdex is also indicated for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion and for the treatment of noninfectious uveitis affecting the posterior segment of the eye.

Injectable Vitamin Products Warning

07-01-2014

The FDA is alerting health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators with “Sunshine Labs” on the label. These products are manufactured by Compound Brothers Dominicana (CB Inc.) and sold as prescription injectable nutritional supplements. However, the FDA has not approved these products and cannot be assured of their safety, effectiveness, or quality.

All lots of nonexpired products from Compound Brothers labeled as Sunshine Labs are being voluntarily recalled by Medical Supply Liquidators. Click here for a listing of all affected products.

Afrezza Inhalation Powder Approved for Diabetes

06-30-2014

The FDA has approved MannKind Corporation’s Afrezza (insulin human) inhalation powder to improve glycemic control in adults with type 1 or type 2 diabetes. Afrezza is a rapid-acting inhaled insulin administered at the beginning of each meal and must be used in combination with long-acting insulin in patients with type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke. The labeling contains a Boxed Warning alerting that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD), and that it should not be used in patients with chronic lung diseases because of this risk. Afrezza has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and will be dispensed with a patient Medication Guide.

New Boxed Warning for Lidocaine Viscous

06-26-2014

The FDA is requiring a Boxed Warning for lidocaine topical 2% (viscous) solution alerting health care providers and caregivers against its use in treating teething pain in infants and children, which may cause serious harm, including death. When too much viscous lidocaine is given to infants and young children, or if they accidentally swallow too much, seizures, severe brain injury, and cardiac problems may result.

Reports of serious adverse events (including death) in infants and young children 5 months to 3.5 years of age given lidocaine 2% viscous solution for mouth pain (including pain due to teething and stomatitis), or with accidental ingestion, have been reviewed by the FDA.

The American Academy of Pediatrics recommends managing teething pain with a chilled (not frozen) teething ring or gently rubbing/massaging with the caregiver’s finger. The FDA recommends against using topical OTC medications for teething pain as some products may cause harm.

Further information can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402790.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

OTC Topical Acne Products Warning

06-25-2014

The FDA is warning that certain OTC topical acne products marketed under various brand names may cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should seek immediate emergency medical attention if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, faintness, or swelling of the eyes, face, lips, or tongue, and should also stop using topical acne products if they develop hives or itching. These serious reactions may occur within minutes to a day or longer after product use and differ from the local skin irritation (redness, burning, dryness, itching, peeling, or slight swelling) that may occur at the application site. It has not been determined if the serious hypersensitivity reactions are triggered by the products’ active ingredients (benzoyl peroxide or salicylic acid), inactive ingredients, or by a combination of both. The FDA is monitoring and evaluating this safety issue. At first use, consumers should apply a small amount of any OTC topical acne product to 1 or 2 small affected areas for 3 days to make sure they do not develop hypersensitivity symptoms.

http://www.fda.gov/Drugs/DrugSafety/ucm400923.htm

Trental Label Changes

06-23-2014

The FDA has approved label changes specifying new dosing recommendations for Sanofi Aventis’ Trental (pentoxifylline) 400 mg extended-release tablets for patients with severe renal impairment (creatinine clearance less than 30 mL/min). For these patients, the Trental dosage should be reduced to 400 mg once daily instead of the usual recommended dosage of 3 times a day. Trental is indicated for the treatment of intermittent claudication on the basis of chronic occlusive arterial disease of the limbs.

Sivextro Approved for Skin Infections

06-23-2014

The FDA has approved Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections caused by susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use.

Docetaxel Safety Warning

06-20-2014

The FDA is warning health care providers and patients that docetaxel injection products contain ethanol, which may cause patients to experience symptoms of alcohol intoxication during and after treatment. The FDA is revising the labels of all docetaxel drug products to warn about this risk. Health care providers should consider the alcohol content of docetaxel products when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications. Patients should avoid driving, operating machinery, or performing other activities that could be dangerous for 1 to 2 hours after docetaxel infusion.

Further information is available at: http://www.fda.gov/Drugs/DrugSafety/ucm401752.htm

General VTE Warning Added to Testosterone Products

06-20-2014

The FDA is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of venous thromboembolism (VTE). The risk of VTE is already included in the labeling of testosterone products as a possible consequence of polycythemia that may occur with testosterone treatment. However, postmarketing reports of VTE unrelated to polycythemia have prompted this new warning.

Marcaine Injection Recall

06-18-2014

Hospira is voluntarily recalling to the user level 1 lot (33-545-DD, NDC 0409-1560-29) of Marcaine (bupivacaine hydrochloride) injection 0.5%, 30 mL, single-dose, preservative-free vials due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. The impacted lot was distributed November 2013 through March 2014 to wholesalers/distributors, hospitals, and clinics nationwide.

Customers should immediately stop use and quarantine all affected product. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for product return. For additional assistance, call Stericycle at 1-888-656-6380 (Monday-Friday, 8 AM–5 PM, EST).

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401724.htm?

Expanded Indication for Lymphoseek

06-17-2014

The FDA has approved Navidea Biopharmaceuticals’ Lymphoseek (technetium Tc 99m tilmanocept) injection for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity. Lymphoseek is currently approved for lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.

FDA Approves Restylane Silk

06-16-2014

The FDA has approved Valeant Pharmaceuticals’ Restylane Silk (hyaluronic acid 20 mg/mL with lidocaine 0.3%) injectable gel, indicated for submucosal implantation for lip augmentation and dermal implantation for the correction of perioral rhytids in patients older than 21 years of age.

Expanded Indication for Gadavist

06-13-2014

The FDA has approved Bayer’s Gadavist (gadobutrol) injection for intravenous use with magnetic resonance imaging (MRI) to assess the presence and extent of malignant breast disease. The approval is based on priority review and it is the first magnetic resonance contrast agent for evaluation of breast cancer. Gadavist was previously approved for use in diagnostic MRI in adults and children (2 years and older) to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the CNS. Gadavist’s label includes a Boxed Warning regarding the risk of nephrogenic systemic fibrosis.

Complera Label Changes

06-13-2014

The FDA has approved label changes specifying new dosing recommendations for Gilead’s Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate). Complera is indicated for use as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment–naive adult patients with HIV-1 RNA 100,000 copies/mL or less at the start of therapy, and in certain virologically suppressed (HIV-1 RNA less than 50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen. New dosing information states that if Complera is coadministered with rifabutin, patients should take an additional rilpivirine 25 mg tablet once daily with a meal for the duration of the rifabutin coadministration.

FDA Approves Generic Actonel 150 mg Tablets

06-12-2014

The FDA has approved Mylan’s risedronate sodium 150 mg tablets, the generic equivalent to Actonel, indicated for the treatment and prevention of osteoporosis in postmenopausal women. Other strengths of risedronate sodium may have additional indications.

Jublia Approved for Onychomycosis

06-10-2014

The FDA has approved Valent Pharmaceuticals’ once-daily Jublia (efinaconazole) 10% topical solution for the treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. Jublia is the first topical triazole agent developed for this use.

FDA Approves Eloctate for Hemophilia A

06-09-2014

The FDA has approved Biogen Idec’s Eloctate (coagulation factor VII [recombinant] Fc fusion protein) injection for the treatment of adults and children with hemophilia A to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes.

Expanded Indication and New Doseform for Reyataz

06-04-2014

The FDA has approved an expanded indication for Reyataz (atazanavir) to include pediatric patients 3 months of age and older weighing at least 10 kg for the treatment of HIV-1 infection in combination with other antiretroviral agents. Reyataz was previously only indicated in adults and pediatric patients at least 6 years of age. The FDA also approved a new oral powder doseform for use in treatment-naive or treatment-experienced pediatric patients who are at least 3 months of age and weighing at least 10 kg and less than 25 kg.

Synera Label Change

06-04-2014

The FDA has approved a label change that allows Galen US’s Synera (lidocaine and tetracaine) topical patch to be used at home. The Synera patch is indicated for use on intact skin in patients 3 years and older to provide local analgesia for superficial venous access and superficial dermatological procedures.

Soliris Injection Recall

06-03-2014

Alexion Pharmaceuticals, Inc. is voluntarily recalling 9 lots (10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A, 10007A, 10008A) of Soliris (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion due to the potential presence of particulate matter in the vials. The affected lots were last shipped on October 30, 2013.

Customers should stop use and arrange for return by contacting Alexion at 1-888-765-4747 (Monday-Friday 8:30 AM-5 PM, EST).

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm399536.htm

FDA Approves Generic Celebrex

06-02-2014

The FDA has approved Teva Pharmaceutical’s celecoxib 50, 100, 200, and 400 mg capsules, the first generic equivalent to Celebrex, indicated for the treatment of rheumatoid arthritis, osteoarthritis, acute pain, ankylosing spondylitis, juvenile rheumatoid arthritis, and primary dysmenorrhea.

Expanded Pediatric Indication for Aloxi

05-28-2014

The FDA has approved an expanded indication for Eisai’s Aloxi (palonosetron hydrochloride) injection to include children aged 1 month to younger than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Aloxi was previously indicated only for use in adult patients.

Expanded Indication for Vectibix

05-27-2014

The FDA has approved an expanded indication for Amgen’s Vectibix (panitumumab) for use in combination with Folfox as first-line treatment in patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC). The FDA approved the drug alongside a genetic test to help health care providers determine whether patients are likely to respond to the drug. Vectibix was previously approved as monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. Vectibix includes a Boxed Warning regarding the risk of dermatologic toxicity.

Dalvance Approved for Skin Infections

05-27-2014

The FDA has approved Durata Therapeutics’ Dalvance (dalbavancin) injection for the treatment of adults with acute bacterial skin and skin structure infections caused by certain susceptible bacteria such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes.

Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Dalvance was granted QIDP designation, making it eligible for priority review because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.

NaturaLyte Recall

05-27-2014

Fresenius Medical Care North America is voluntarily recalling 56 lots of NaturaLyte Liquid Bicarbonate concentrate 6.4 L intended for use in hemodialysis machines because they may develop higher bacteria levels than is allowed by the company’s specification. The bacteria was identified as Halomonas (species 1, 2, 3), a gram-negative bacteria typically found in water with high salinity. Bacterial contamination of the dialysate may lead to bacteremia or systemic infection and should be removed and returned.

Customer notifications were published on April 10 and May 1, 2014, and include a list of affected lot numbers (http://www.fmcna.com).

FDA Approves Entyvio for Ulcerative Colitis or Crohn Disease

05-21-2014

The FDA has approved Takeda Pharmaceutical’s Entyvio (vedolizumab) 300 mg infusion for the treatment of adults with moderately to severely active ulcerative colitis and Crohn disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Entyvio will be dispensed with a patient Medication Guide.

Labetalol Hydrochloride Injection Recall

05-19-2014

Hospira is voluntarily recalling to the user level 1 lot (36-225-DD, expiration date December 1, 2015, NDC 0409-2267-20) of labetalol hydrochloride injection 100 mg/20 mL (5 mg/mL) 20 mL multidose vials due to the presence of embedded particulate within the glass vial and visible particles floating in the solution. The embedded particulate was identified as stainless steel and the floating particulate as iron oxide. The affected lot was distributed in February 2014 to wholesalers/distributors, hospitals, and clinics nationwide. Labetalol hydrochloride is indicated for the management of hypertension.

Customers should immediately stop use and quarantine all affected product. For additional assistance, call Stericycle at 1-888-386-2076 (Monday-Friday, 8 AM to 5 PM EST). For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187.

FDA Lowers Recommended Eszopiclone (Lunesta) Dose

05-16-2014

The FDA is requiring the starting dose of Lunesta (eszopiclone) oral tablets, indicated for the treatment of insomnia, to be lowered to 1 mg at bedtime. The change was prompted after a study found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination lasting more than 11 hours after dosing. The 1 mg starting dose is recommended for women and men because they are both equally susceptible. If needed, the dose can be increased to 2 or 3 mg, but higher doses are more likely to result in next-day impairment. Patients taking a 3 mg dose should be cautioned against driving and other activities that require complete mental alertness the day after use.

Dobutamine Injection Recall

05-16-2014

Hospira is voluntarily recalling to the user level 1 lot (27-352-DK, NDC 0409-2344-02) of dobutamine injection 250 mg/20 mL, single-dose, fliptop vials due to the potential presence of glass particles and/or particulate matter in the vials. The impacted lot was distributed August 2013 through September 2013 to distributors/wholesalers, hospitals, and clinics nationwide.

Customers should immediately stop use and quarantine all affected products. For additional assistance, call Stericycle at 1-877-907-9956 (Monday-Friday, 8 AM - 5 PM, EST). For medical inquiries, call Hospira Medical Communications at 1-800-615-0187 (24/7).

http://www.fda.gov/Safety/Recalls/ucm397339.htm

Kuvan Labeling Changes

05-15-2014

The FDA has approved label changes specifying new dosing recommendations for BioMarin Pharmaceuticals’ Kuvan (sapropterin dihydrochloride) oral tablets and powder for oral solution to include patients 1 month to 6 years of age. Previous recommendations included only patients 4 years and older. For patients 1 month to 6 years of age, the recommended starting dosage is 10 mg/kg once daily. For patients 7 years and older, the recommended starting dosage is 10 to 20 mg/kg once daily. Kuvan is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria in conjunction with a phenylalanine-restricted diet.

Avandamet Label Changes

05-14-2014

The FDA has approved label changes specifying new dosing recommendations for GlaxoSmithKline’s Avandamet (rosiglitazone/metformin hydrochloride), indicated as an adjunct to diet and exercise for the treatment of type 2 diabetes. Dosing now includes information regarding patients inadequately controlled on diet and exercise who are starting Avandamet without previous rosiglitazone and/or metformin hydrochloride therapy. The recommended starting dose of Avandamet for these patients is 2 mg/500 mg administered once or twice daily. For patients with HbA1c greater than 11% or fasting plasma glucose greater than 270 mg/dL, a starting dose of 2 mg/500 mg twice daily may be considered. The dose of Avandamet may be increased in increments of 2 mg/500 mg per day given in divided doses if patients are not adequately controlled after 4 weeks. The maximum dose of Avandamet is 8 mg/2,000 mg per day. Avandamet has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is dispensed with a patient Medication Guide.

Zontivity Approved to Reduce Risk of Heart Attacks and Stroke

05-09-2014

The FDA has approved Merck’s Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs. Zontivity, an anti-platelet agent, is the first in a new class of drug called a protease-activated receptor-1 (PAR-1) antagonist. Zontivity carries a Boxed Warning regarding an increased risk of bleeding and will be dispensed with a patient Medication Guide.

FDA Approves Epanova for Severe Hypertriglyceridemia

05-07-2014

The FDA has approved AstraZeneca’s Epanova (omega-3-carboxylic acids) capsules, indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

Nitroglycerin in Dextrose 5% Injection Shortage and Import of Nitronal

05-06-2014

The FDA is temporarily allowing the importation of Nitronal (glyceryl trinitrate) through Arbor Pharmaceuticals from Pohl-Boskamp of Germany to alleviate the nitroglycerin in dextrose 5% shortage. Nitronal is available in 25 mL ampules and 50 mL vials at a concentration of 1 mg/mL, which may be diluted to obtain concentrations similar to those of FDA-approved products. To place an order, contact Arbor Pharmaceuticals at 1-866-516-4950, extension 0 (Monday-Friday, 9 AM to 5 PM, EST), or email GMB-SPS-ARBOR@cordlogistics.com.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm#nitronal

http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM396024.pdf

Edurant Label Changes

05-06-2014

The FDA has approved label changes specifying new dosing recommendations for Janssen’s Edurant (rilpivirine) for patients concomitantly receiving rifabutin. For these patients, the Edurant dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin coadministration is stopped, the Edurant dose should be decreased to 25 mg once daily, taken with a meal. Edurant, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in antiretroviral treatment–naive adult patients with HIV-1 RNA 100,000 copies/mL or less at the start of therapy.

Incruse Ellipta Approved for COPD

05-01-2014

The FDA has approved GlaxoSmithKline’s Incruse Ellipta (umeclidinium) once-daily inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The company anticipates a fourth quarter 2014 launch.

FDA Approves Zykadia for Late-Stage Lung Cancer

04-30-2014

The FDA has approved Novartis Pharmaceuticals’ Zykadia (ceritinib) capsules for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non–small cell lung cancer who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established.

FDA Approves Liquid Purixan for ALL

04-30-2014

The FDA has approved Rare Disease Therapeutics’ Purixan (mercaptopurine) 20 mg/mL oral suspension for the treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a combination maintenance therapy regimen.

Safety Alert Reminder for Acetaminophen 325 mg Combination Products

04-29-2014

The FDA is reminding health care providers to discontinue prescribing and dispensing prescription combination drug products that contain more than acetaminophen 325 mg per tablet, capsule, or other dosage unit. These products are no longer considered safe by the FDA. Pharmacists are encouraged to return these products to the wholesaler or manufacturer. These products were voluntarily withdrawn by manufacturers at the agency’s request to protect consumers from the risk of severe liver damage as a result of taking too much acetaminophen. A 2-tablet or 2-capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units).

http://www.fda.gov/Drugs/DrugSafety/ucm394916.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Super Arthgold Recall

04-28-2014

Nano Well-being Health is voluntarily recalling 2 lots (L1P1-6100, expiration date June 25, 2016; lot L1P2-6000, expiration date September 16, 2016) of Super Arthgold 500 mg capsules at the consumer level after FDA lab analysis found the product to contain chlorzoxazone, diclofenac, and indomethacin, making it an unapproved new drug. Super Arthgold is sold as a dietary supplement for joint pain and arthritis.

Use of this product containing the undeclared drug ingredients increases the risk of fatal adverse events in consumers and patients with underlying illnesses, including known allergy to the hidden ingredients, or in those with cardiac, GI, hepatic, or renal conditions, or those who have recently had cardiac bypass graft surgery. The affected product contains nonsteroidal anti-inflammatory drugs (NSAIDs) and other ingredients that may cause accidental overdose when taken with another NSAID concurrently, thus increasing the risk for NSAID-associated adverse events, including myocardial infarction, stroke, congestive heart failure, renal toxicity, as well as bleeding, ulceration, or perforation of the stomach or intestines.

Nano Well-being Health is notifying its distributors and customers by letter and phone call, and is arranging for replacement of all recalled products. Customers with affected product should stop its use and return it to place of purchase.

Lotrisone Cream Label Changes

04-24-2014

The FDA has approved label changes specifying new dosing recommendations for Merck’s Lotrisone (betamethasone/clotrimazole) cream to include a maximum dose of 45 grams per week. Lotrisone is indicated for topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Lotrisone is dispensed with a patient Medication Guide.

Adcetris Label Changes

04-24-2014

The FDA has approved label changes specifying new dosing recommendations for Seattle Genetics’ Adcetris (brentuximab vedotin) for patients with renal and hepatic impairment. The recommended starting doses in patients with hepatic impairment or severe renal impairment (creatinine clearance less than 30 mL/min) is 1.2 mg/kg administered as an IV infusion over 30 minutes every 3 weeks. Adcetris is indicated for the treatment of relapsed/refractory Hodgkin lymphoma and relapsed/refractory systemic anaplastic large cell lymphoma.

FDA Approves Sylvant for Castleman Disease

04-24-2014

The FDA has approved Janssen Biotech’s Sylvant (siltuximab) injection for the treatment of multicentric Castleman disease (MCD), a rare blood disorder similar to lymphoma. Sylvant is intended for patients with MCD who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative and will be dispensed with a patient Medication Guide.

Epidural Corticosteroid Injection Risk

04-23-2014

The FDA is warning that epidural injection of corticosteroids, including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone, may result in rare but serious adverse events such as loss of vision, stroke, paralysis, and death. The injections are administered to treat neck and back pain, as well as radiating pain in the arms and legs. The safety and effectiveness of epidural corticosteroid administration have not been established, and the FDA has not approved corticosteroids for this use. The FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids describing these risks. An FDA Advisory Committee meeting will be convened in late 2014 to determine if further actions are necessary.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Marcaine Recall

04-23-2014

Hospira is voluntarily recalling to the user level 1 lot (34-440-DD, NDC 0409-1559-10) of Marcaine 0.25% (bupivacaine HCl injection) in 10 mL single-dose, preservative-free vials because of a confirmed customer report of discolored solution with visible particles embedded in the glass. The impacted lot was distributed December 2013 through January 2014 to wholesalers/distributors, hospitals, and clinics nationwide.

Customers should quarantine all affected products. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted products to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-877-546-7642 (Monday-Friday, 8 AM- 5 PM, EST).

FDA Approves Generic Ortho Evra Patch

04-22-2014

The FDA has approved Mylan’s Xulane (norelgestromin/ethinyl estradiol) transdermal system, the generic version of Janssen Pharmaceuticals' Ortho Evra, indicated for the prevention of pregnancy.

FDA Approves Cyramza for Stomach Cancer

04-22-2014

The FDA has approved Eli Lilly’s Cyramza (ramucirumab) 10 mg/mL injection solution for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. Cyramza is intended for patients whose cancer is unresectable or metastatic after being treated with a fluoropyrimidine- or platinum-containing therapy. Cyramza’s labeling includes a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal events.

Expanded Indication for Arzerra

04-21-2014

The FDA has approved an expanded indication for GlaxoSmithKline’s Arzerra (ofatumumab) to include the treatment of previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil in patients for whom fludarabine-based therapy is considered inappropriate. Arzerra is also indicated for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

Lidocaine Hydrochloride Injection Recall

04-21-2014

Hospira is voluntarily recalling one lot of lidocaine hydrochloride injection 10 mg/mL in 30 mL single-dose, preservative-free vials because of a confirmed customer report of orange and black particulate, identified as iron oxide, within the solution and imbedded in the glass vials. Lidocaine hydrochloride injection is indicated for the production of local and regional anesthesia and for the management of cardiac arrhythmias.

Hospira will be notifying direct distributors and will arrange for the affected product to be returned. Customers should quarantine any affected product. For more information, contact Stericycle at 1-888-835-2723.

Cubicin Recall

04-21-2014

Cubist Pharmaceuticals is voluntarily recalling one lot (#280453F) of Cubicin (daptomycin) 500 mg injection at the user level due to the presence of glass particles. Cubicin is indicated for the treatment of complicated skin and skin structure infections, as well as for the treatment of Staphylococcus aureus bloodstream infections.

Customers should quarantine all affected products and arrange for return by contacting Cubist at 855-534-8309.

Avinza Expanded Boxed Warning and Label Changes for Extended-Release/Long-Acting Opioids

04-18-2014

The FDA has expanded the Boxed Warning for the class of extended-release and long-acting opioid analgesics, including Avinza (morphine), Kadian (morphine), MS Contin (morphine), and OxyContin (oxycodone). The Boxed Warning now includes information regarding prolonged use of opioids during pregnancy and the potential for neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

The FDA also approved new Avinza dosing recommendations for patients who are not opioid tolerant.

FDA Approves Ragwitek for Short Ragweed Pollen Allergies

04-18-2014

The FDA has approved Merck’s Ragwitek (ragweed extract) sublingual tablet to treat short ragweed pollen–induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age. The prescribing information for Ragwitek includes a Boxed Warning regarding severe allergic reactions and it is dispensed with a patient Medication Guide.

Tanzeum Approved for Type 2 Diabetes

04-16-2014

The FDA has approved GlaxoSmithKline’s Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Tanzeum has a Boxed Warning regarding the possible risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2. Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and will be dispensed with a patient Medication Guide. GlaxoSmithKline expects to launch Tanzeum in the third quarter of 2014.

FDA Approves Grastek Allergy Immunotherapy

04-15-2014

The FDA has approved Merck’s Grastek (Timothy grass pollen allergen extract) sublingual tablets (2800 bioequivalent allergy units [BAU]) as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens in patients 5 through 65 years of age. Grastek is not indicated for the immediate relief of allergic symptoms. The prescribing information for Grastek includes a Boxed Warning regarding severe allergic reactions and it is dispensed with a patient Medication Guide.

Xyrem Label Changes

04-15-2014

The FDA has approved label changes specifying dosing recommendations for Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution due to pharmacokinetic and pharmacodynamic interactions observed when Xyrem is coadministered with divalproex sodium. For patients already stabilized on Xyrem, the addition of divalproex sodium should be accompanied by at least a 20% initial nightly dose reduction of Xyrem. When introducing Xyrem for patients already taking divalproex sodium, health care providers should use a lower starting dose of Xyrem. Health care providers should monitor patient response and adjust dosage accordingly. Xyrem is available only through a restricted distribution program and includes a Boxed Warning regarding CNS depression, abuse, and misuse.

FDA Approves Generic VESIcare

04-07-2014

The FDA has approved Teva Pharmaceuticals’ solifenacin succinate 5 and 10 mg tablets, the generic equivalent to VESIcare, indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Expanded Indication for Pradaxa

04-07-2014

The FDA has approved an expanded indication for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) capsules to include the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. Pradaxa is also indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Pradaxa labeling now also includes an updated Boxed Warning regarding the risk of spinal/epidural hematoma in patients receiving neuraxial anesthesia or undergoing spinal puncture, in addition to the existing warning that premature discontinuation increases the risk of thrombotic events. Pradaxa is dispensed with a patient Medication Guide.

Expanded Indication for Kalbitor

04-04-2014

The FDA has approved an expanded indication for Dyax’s Kalbitor (ecallantide) to include the treatment of acute attacks of hereditary angioedema in patients 12 years of age and older. Kalbitor was previously approved for treatment in patients16 years of age and older. The prescribing information for Kalbitor includes a Boxed Warning regarding the risk of anaphylaxis and it is dispensed with a patient Medication Guide.

FDA Approves Evzio for Opioid Overdose

04-03-2014

The FDA has approved kaléo’s Evzio (naloxone hydrochloride) injection for the emergency treatment of known or suspected opioid overdose characterized by decreased breathing or heart rate, or loss of consciousness. Evzio is delivered via a hand-held autoinjector that can be stored in a pocket or medicine cabinet and can administered by a family member or caregiver. Previous naloxone treatments required administration via syringe and were most commonly used by health care providers.

FDA Approves Oralair Allergy Immunotherapy

04-02-2014

The FDA has approved Greer’s Oralair once-daily sublingual immunotherapy tablet for the treatment of allergic rhinitis with or without conjunctivitis that is induced by certain grass pollens in persons 10 through 65 years of age. The prescribing information includes a Boxed Warning that severe allergic reactions such as anaphylaxis can occur. After administration of the first dose under supervision in a health care provider’s office, Oralair can be taken at home. Patients must also be prescribed an epinephrine auto-injector and trained on how to use it due to the risk of anaphylaxis.

Expanded Age Indication for Adacel

04-02-2014

The FDA has approved an expanded age indication for Sanofi Pasteur’s Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 10 to 64 years of age. Adacel was previously indicated in persons 11 to 64 years of age.

Nexium 24HR Available OTC

04-01-2014

The FDA has approved Pfizer’s Nexium 24HR (esomeprazole 20 mg) for OTC availability.

FDA Approves Alprolix for Hemophilia B

03-31-2014

The FDA has approved Biogen Idec’s Alprolix (coagulation factor IX [recombinant] Fc fusion protein) lyophilized powder for solution for the control and prevention of bleeding episodes; perioperative management; and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia B.

alli Capsules Recalled

03-31-2014

GlaxoSmithKline Consumer Healthcare is voluntarily recalling all alli (orlistat) capsules from the US and Puerto Rico at the retail level because some packages may have been tampered with and may not contain authentic product. A variety of tablets and capsules in different shapes and colors were reported to be found inside alli bottles; some bottles were also missing labels and had inauthentic tamper-evident seals. alli is indicated for weight loss in overweight adults 18 years and older in conjunction with a reduced-calorie and low-fat diet.

Consumers who have product they are concerned about should not use it and should contact GlaxoSmithKline at 1-800-671-2554 for further instructions; if they have consumed questionable product, they should also contact their health care provider.

Expanded Indication for Topamax

03-31-2014

The FDA has approved an expanded indication for Janssen’s Topamax (topiramate) tablets to include the prevention of migraine headaches in adolescents 12 to 17 years of age. Topamax was previously approved for migraine prevention only in adults, as well as initial monotherapy in patients 2 years and older with partial-onset or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients 2 years and older with partial-onset seizures, primary generalized tonic-clinic seizures, or seizures associated with Lennox-Gastaut syndrome. Topamax is dispensed with a patient Medication Guide.

Expanded Indication for Baraclude

03-26-2014

The FDA has approved an expanded indication for Bristol-Myers Squibb’s Baraclude (entecavir) to include children at least 2 years of age for the treatment of chronic hepatitis B virus infection with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. Baraclude was previously indicated only in adults.

Otezla Approved for Psoriatic Arthritis

03-24-2014

The FDA has approved Celgene’s Otezla (apremilast) oral tablets for the treatment of adult patients with active psoriatic arthritis. The FDA is requiring a pregnancy exposure registry as a postmarketing requirement to assess the risks to pregnant women exposed to Otezla.

FDA Approves Generic Mepron Suspension

03-24-2014

The FDA has approved Amneal Pharmaceuticals’ atovaquone 750 mg/5 mL oral suspension, the generic version of Mepron, indicated for the prevention of Pneumocystis carinii pneumonia (PCP) in patients intolerant to trimethoprim-sulfamethoxazole (TMP-SMZ), as well as for the short-term oral treatment of mild to moderate PCP in patients intolerant to TMP-SMZ.

Expanded Xolair Indication

03-24-2014

The FDA has approved an expanded indication for Xolair (omalizumab) injection to include the treatment of chronic idiopathic urticaria in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment. Xolair is also indicated for the treatment of moderate to severe persistent asthma in adults and adolescents 12 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair labeling contains a Boxed Warning regarding the risk of anaphylaxis after administration.

Pleo Homeopathic Drugs Recalled

03-21-2014

Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms. These products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.

Terra-Medica is notifying its customers by letter and e-mail and is arranging for return of all recalled products. Consumers and distributors that have product subject to the recall should stop using the products and return them to the point of purchase. Consumers can contact Terra-Medica’s Customer Service Department at 1-888-415-0535, ext. 1, Monday through Friday, 8 AM to 5 PM PST.

For more information and to see the affected lots, visit http://www.fda.gov/Safety/Recalls/ucm389832.htm

Neuraceq Approved

03-21-2014

The FDA has approved Piramal Imaging’s Neuraceq (florbetaben F18) injection for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline.

FDA Approves Impavido for Leishmaniasis

03-20-2014

The FDA has approved Paladin Therapeutics’ Impavido (miltefosine) for the treatment of visceral, cutaneous, and mucosal leishmaniasis in patients 12 years and older. Impavido labeling will include a Boxed Warning alerting patients and health care providers of the risk of fetal harm in pregnant women and advising women to use effective contraception during and for 5 months after therapy.

Expanded Labeling for Menopur and Bravelle

03-19-2014

The FDA has approved new labeling for Ferring Pharmaceuticals’ fertility products, Menopur (menotropins for injection) and Bravelle (urofollitropin for injection, purified) to be safely mixed and administered in a single injection. Menopur and Bravelle are indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in the assisted reproductive technology program. Bravelle is also indicated for ovulation induction.

Pancreaze – New Strength

03-19-2014

The FDA has approved a new 2,600 lipase unit capsule for Janssen Pharmaceuticals’ Pancreaze (pancrelipase) to easier facilitate dosing in infants. Pancreaze is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions and is dispensed with a patient Medication Guide.

FDA Approves Hemangeol

03-18-2014

The FDA has approved Pierre Fabre Dermatologie’s Hemangeol (propranolol hydrochloride) oral solution, the first approved treatment for infantile hemangioma. Hemangeol will be available June 2014.

Revised Labeling for Eliquis

03-17-2014

The FDA has approved labeling changes for Bristol-Myers Squibb’s Eliquis (apixaban) oral tablets to include an expanded indication for the prophylaxis of deep vein thrombosis in patients who have undergone hip or knee surgery. An updated Boxed Warning has also been added regarding the increased risk of epidural or spinal hematoma that may result in long-term paralysis in patients administered neuraxial anesthesia. The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of Eliquis outweigh the potential risks in patients with nonvalvular atrial fibrillation, and it will be dispensed with a patient Medication Guide.

Vpriv Recall

03-17-2014

Shire Pharmaceuticals is voluntarily recalling 1 batch packaged into 3 lots (FEW13-001, FEW13-002, and FED13-006; expiration date October 2015) of Vpriv (velaglucerase alfa) lyophilized powder for intravenous use due to the presence of visible particulate matter identified as stainless steel and barium sulfate. The matter was found in a small number of vials from the 3 lots. An investigation by Shire identified the third party supplier fill finish process as the cause of the particulate matter. The affected lots were distributed nationwide to hospitals, infusion clinics, patients, and home health agencies. Vpriv is indicated for long-term enzyme replacement therapy for pediatric and adult patients with type 1 Gaucher disease.

Customers should quarantine all affected product and arrange for return by contacting Shire at 1-888-899-9293, Monday through Friday, 8 AM to 5 PM EST.

FDA Approves Xartemis XR for Severe Acute Pain

03-13-2014

The FDA has approved Mallinckrodt’s Xartemis XR (oxycodone 7.5 mg/acetaminophen 325 mg) extended-release tablets for the management of acute pain severe enough to require opioid treatment for which alternative treatment options are inadequate. Xartemis XR contains a Boxed Warning regarding the risks of addiction, abuse, and misuse; life-threatening respiratory depression; accidental overdose; neonatal withdrawal syndrome; and hepatotoxicity and will be dispensed with a patient Medication Guide.

FDA Approves Qudexy XR for Epilepsy

03-12-2014

The FDA has approved Upsher-Smith Laboratories’ Qudexy XR (topiramate) once-daily, extended-release capsules indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. Qudexy XR is also approved as adjunctive therapy in patients 2 years of age and older with POS, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients in the second quarter of 2014.

Metformin HCl Recall

03-11-2014

Caraco Pharmaceutical Laboratories is voluntarily recalling 1 lot (JKM2433A, expiration date March 2016) of metformin HCl 500 mg extended-release tablets after gabapentin tablets were found in a 500-count bottle (NDC 62756-142-02) manufactured by Sun Pharmaceutical.

Expanded Boxed Warning for Xarelto

03-11-2014

The FDA has expanded the Boxed Warning for Xarelto (rivaroxaban) to now include the following statement regarding factors that can increase the risk of epidural or spinal hematomas: optimal timing between the administration of Xarelto and neuraxial procedures is not known. The Boxed Warning had previously stated that factors that can increase the risk of epidural or spinal hematomas in patients being treated with Xarelto include use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; or a history of spinal deformity or spinal surgery. Xarelto is indicated to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation; for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and PE; and for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement.

FDA Approves Generic Xeloda Tablets

03-10-2014

The FDA has approved Teva Pharmaceutical’s capecitabine 150 and 500 mg tablets, the generic version of Xeloda, indicated as adjuvant treatment of patients with Duke stage C colon cancer, monotherapy for metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred, in combination with docetaxel for metastatic breast cancer after failure of prior anthracycline-containing therapy, and as monotherapy in patients with metastatic breast cancer who are resistant to paclitaxel and an anthracycline-containing regimen. Capecitabine carries a Boxed Warning regarding the risk of a dangerous warfarin interaction.

Expanded Boxed Warning for Nizoral Tablets

03-07-2014

The FDA has expanded the Boxed Warning for Janssen Pharmaceutical’s Nizoral (ketoconazole) tablets. The Boxed Warning now includes the following statement: Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. The Boxed Warning had previously stated that ketoconazole was contraindicated with cisapride, dofetilide, quinidine, and pimozide. Nizoral tablets are indicated for treatment of the following systemic fungal infections in patients who have not responded to or are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.

Effexor XR 150 mg and Venlafaxine HCl 150 mg Extended-Release Recall

03-07-2014

Pfizer is voluntarily recalling 1 lot of 30-count and 1 lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules (lot numbers V130142 and V130140, expiration date October 2015) due to the possible presence of Tikosyn (dofetilide) 0.25 mg capsules within the same package. One lot (V130014, expiration date August 2015) of 90-count Greenstone LLC-branded venlafaxine HCl 150 mg extended-release capsules is also being recalled for the possible presence of Tikosyn. Accidental ingestion of dofetilide in patients taking venlafaxine could lead to serious (some potentially fatal) adverse effects. Existing inventory of the affected lots should be immediately quarantined and returned. Customers should contact Stericycle at 1-888-345-0481, Monday through Friday, 8 AM to 5 PM EST to arrange for product return. Patients with questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985, Monday through Thursday, 9 AM to 8 PM EST or Friday, 9 AM to 5 PM EST.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm

Doribax Safety Alert

03-07-2014

The FDA has concluded that Shionogi Pharma’s Doribax (doripenem) carries an increased risk of death and lower clinical cure rates compared with the use of Merck Sharp & Dohme’s Primaxim IV (imipenem/cilastatin) when used to treat ventilator-associated pneumonia. Based on an FDA analysis of data from a 3-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, the FDA approved changes to the Doribax prescribing information to now include a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia.

Health care providers should consider whether the benefits of Doribax are likely to exceed its potential risks in patients who develop ventilator-associated pneumonia. Doribax is still considered safe and effective for its FDA-approved indications.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388328.htm

Dianeal PD-2 Recall

03-06-2014

Baxter International is voluntarily recalling 1 lot (C903799, expiration date May 2015, product code L5B9710) of Dianeal PD-2 peritoneal dialysis solution with 1.5% dextrose 6,000 mL (Ambu-Flex II) after complaints of particulate matter, identified as mold, being found in the container as a result of a leak. Administration of the contaminated product could result in life-threatening fungal peritoneal infection or sepsis. Health care providers should quarantine any affected product and arrange for its return by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7 AM to 6 PM CST. Dianeal PD-2 is indicated for the treatment of renal failure, poisoning by dialyzable toxins, intractable edema, hyperkalemia and hypercalcemia, azotemia and uremia, and hepatic coma.

Expanded Indication for Nexium IV

03-06-2014

The FDA has approved an expanded indication for AztraZeneca’s Nexium IV (esomeprazole sodium) injection to include risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy in adults. Nexium IV is also indicated for short-term treatment of gastroesophageal reflux disease with erosive esophagitis in adults and pediatric patients 1 month to 17 years of age when therapy with oral esomeprazole is not possible or appropriate.

FDA Approves Generic Evista Tablets

03-05-2014

The FDA has approved Teva Pharmaceutical’s raloxifene 60 mg tablets, the generic version of Evista, indicated for the treatment and prevention of osteoporosis, reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis, and reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. Evista carries a Boxed Warning regarding the increased risk of venous thromboembolism and death from stroke and is dispensed with a patient Medication Guide.

Bivigam Recall

03-03-2014

Biotest Pharmaceuticals is voluntarily recalling several lots of Bivigam (immune globulin intravenous [human]) 10% liquid in 100 mL vials because of the potential that a small percentage of the vials may exhibit an integrity defect, which could result in product leakage. Vials from the affected lots should be quarantined and returned to the manufacturer. Bivigam is indicated for the treatment of patients with primary humoral immunodeficiency.

FDA Approves Tivorbex for Acute Pain

02-26-2014

The FDA has approved Iroko Pharmaceuticals’ Tivorbex (indomethacin) 20 and 40 mg capsules, a nonsteroidal anti-inflammatory drug for the treatment of mild to moderate acute pain in adults. Tivorbex capsules were approved at dosage strengths 20 percent lower than those of currently available indomethacin products. Tivorbex carries a Boxed Warning regarding the increased risk of serious cardiovascular and gastrointestinal events, and is dispensed with a patient Medication Guide.

Myalept Approved to Treat Rare Metabolic Disease

02-25-2014

The FDA has approved Amylin Pharmaceuticals’ Myalept (metreleptin) injection as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. Myalept is not approved for use in patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy. Myalept is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) and will be dispensed with a patient Medication Guide.

Generic Avelox Tablets Approved

02-24-2014

The FDA has approved Teva Pharmaceuticals’ moxifloxacin hydrochloride 400 mg tablets, the generic version of Avelox, indicated for the treatment of acute bacterial exacerbation of chronic bronchitis; acute bacterial sinusitis; community-acquired pneumonia; complicated intra-abdominal infections; complicated skin and skin structure infections; and uncomplicated skin and skin structure infections.

Expanded Indication for Kalydeco

02-24-2014

The FDA has approved an expanded indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor) tablets to include the treatment of cystic fibrosis in patients 6 years and older who have 1 of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. Kalydeco was previously indicated only for treatment of cystic fibrosis in patients 6 years and older with a G551D mutation in the CFTR gene.

Etomidate Injection Recall

02-21-2014

Mylan has announced that its subsidiary Agila Specialties is issuing a voluntary nationwide recall of 10 lots of etomidate injection 2 mg/mL in 10 mL and 20 mL vials due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiration date on the outer carton; and the potential for illegible/missing lot number and expiration date on individual vials. Customers that have the recalled product should stop use and discontinue distribution. All recalled products bear a Pfizer label.

    10 mL (lot number; expiration date)
  • 5001023; 9/14
  • 5000983; 8/14
  • 5000986; 8/14
    20 mL (lot number; expiration date)
  • 5001012; 9/14
  • 5000927; 6/14
  • 5000931; 6/14
  • 5000936; 6/14
  • 5000942; 6/14
  • 5001071; 10/14
  • 5001040; 9/14

Consumers with questions regarding this recall can contact Mylan Customer Service at 1-800-848-0462 Monday through Friday between 8:00 AM and 5:00 PM EST. Etomidate is indicated for induction of general anesthesia and for the supplementation of subpotent anesthetic agents during maintenance of anesthesia for short operative procedures.

FDA Approves Vimizim for MPS IVA

02-19-2014

The FDA has approved BioMarin Pharmaceutical’s Vimizim (elosulfase alfa) injection for the treatment of mucopolysaccharidosis type IVA (Morquio A syndrome; MPS IVA). Vimizim labeling contains a Boxed Warning regarding the risk of anaphylaxis and was granted priority review.

FDA Approves Northera for Neurogenic Orthostatic Hypotension

02-19-2014

The FDA has approved Chelsea Therapeutics’ Northera (droxidopa) capsules for the treatment of neurogenic orthostatic hypotension. Northera labeling contains a Boxed Warning regarding the risk of supine hypertension and was approved under the FDA’s accelerated approval program.

L-citrulline Recalled

02-18-2014

The chemical compounding firm Medisca is voluntarily recalling certain lots of its pharmaceutical grade L-citrulline product after FDA testing indicated that it does not contain L-citrulline, but instead contains N-acetyl-leucine, which is used to treat acute vestibular vertigo. L-citrulline, an amino acid used to treat urea cycle disorders mainly in children, is supplied as a powder that may also be compounded into tablets, capsules, or liquids. Health care providers should discontinue dispensing from these lots: 95482/A, 95482/B, 95482/C, 95482/D; 96453/A, 96453/B, 96453/C, 96453/D. Patients should be contacted and all unused product should be returned to Medisca. The FDA has received several adverse event reports associated with L-citrulline and is investigating reports that may include additional lot numbers.

Acetylcysteine Solution 10% Recalled

02-18-2014

Ben Venue Laboratories has notified health care providers of a nationwide voluntary product recall of Roxane Laboratories’ acetylcysteine solution 10%, 30 mL per vial, (lot 2005479, expiration date March 2014, NDC 0054-3025-02) due to the discovery of a single visible glass particle in a vial within the recalled lot. Health care providers should not use the affected product lot and should immediately quarantine any product for return. Patients who may have received the affected product should return it to their pharmacist. Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218 (1-800-633-1422).

New Boxed Warning for Cozaar

02-13-2014

The FDA has approved a new Boxed Warning for Cozaar (losartan) alerting health care providers that the drug should be discontinued as soon as possible when pregnancy is detected and that drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Cozaar is indicated for the treatment of hypertension, to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for the treatment of diabetic neuropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

Expanded Indication for Imbruvica

02-12-2014

The FDA has approved an expanded indication for Pharmacyclics’ Imbruvica (ibrutinib) to include the treatment of chronic lymphocytic leukemia patients who have received at least 1 previous therapy. Imbruvica is also approved for the treatment of mantle cell lymphoma in patients who have received at least 1 prior therapy.

Generic Hectorol Injection Launched

02-07-2014

Sandoz has launched doxercalciferol injection 4 mcg/2mL single-dose vials, the first generic version of Hectorol, indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Revatio Label Changes

02-04-2014

The FDA has approved label changes specifying new dosing recommendations for Revatio (sildenafil citrate). The new recommended dose for the tablets and oral suspension is 5 or 20 mg three times a day, and 2.5 or 10 mg three times a day for the injection. Data from a clinical study evaluating sildenafil doses of 1 mg, 5 mg, and 20 mg showed that there were no significant differences in the effects on hemodynamic variables with lower doses. Revatio is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening.

Testosterone Product Safety Alert

02-03-2014

The FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA is evaluating information from 2 separate studies that suggest an increased risk of cardiovascular events among groups of men prescribed testosterone therapy, although the agency has not concluded that these products increase the risk of stroke, heart attack, or death. Testosterone products are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care providers. Health care providers should consider whether the benefits of FDA-approved testosterone treatment are likely to exceed the potential risk of treatment. The FDA will communicate final conclusions and recommendations when the evaluation is complete.

FDA Approves Hetlioz

01-31-2014

The FDA has approved Vanda Pharmaceuticals Hetlioz (tasimelteon) capsules for the treatment of non-24-hour sleep-wake disorder in totally blind individuals. “Non-24” is a chronic circadian rhythm disorder in the blind that causes problems with the timing of sleep. Vanda anticipates commercial availability in the second quarter of 2014.

Expanded Indication for ActHIB

01-28-2014

The FDA has approved Sanofi Pasteur’s ActHIB (Haemophilus influenzae type B [Hib] conjugate vaccine) for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive disease caused by Haemophilus influenzae type B. It was previously approved for infants and children 2 to 18 months of age. ActHIB is also approved for the active immunization of children 15 to 18 months of age for prevention of invasive disease caused by Hib and diphtheria, tetanus, and pertussis when reconstituted with Tripedia (DTaP) vaccine.

Trufill n-BCA Liquid Embolic System Recalled

01-22-2014

Codman Neuro has recalled Trufill n-BCA liquid embolic system due to incorrect instructions for use. The product instructions should have stated “A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus” instead of the incorrect “A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels, resulting in neurological deficits, pulmonary emboli, or death.

The affected product, manufactured between February 25, 2010, and October 31, 2013, was distributed to hospitals and surgical centers and includes the following product codes (all lots): 631400 (two 1 g tubes nBCA) and 631500 (one 1 g tube nBCA). Customers may contact Codman Neuro for more information or to report any malfunction or adverse event at 1-866-491-0974, option 2, Monday-Friday, 7 AM-6:30 PM, EST.

Sodium Chloride 0.9% Safety Alert

01-21-2014

A shortage of sodium chloride 0.9% injection in liter bags has led some hospitals to administer sodium chloride for irrigation 0.9% as an alternative to the injection. However, this product does not meet the same specifications of the sterile injection and should not be used; sterility requirements and limits on particulate matter differ between these 2 products.

For more information concerning the contraindicated use of irrigation solution intravenously, as well as information for hospitals to consider during this shortage, see the health bulletin.

Iclusig Available in the US

01-20-2014

Ariad Pharmaceuticals has announced the commercial availability of Iclusig (ponatinib) in the US for the treatment of adult patients with refractory chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia. Ariad began shipping Iclusig to its exclusive specialty pharmacy Biologics, which is now filling prescriptions and distributing the medication.

As a result of an investigation that revealed a steady increase in the number of serious vascular occlusion events identified through continued safety monitoring, on October 31, 2013, the FDA requested and Ariad agreed to voluntarily suspend marketing of Iclusig's.

The investigation represented a significant change in Iclusig's safety profile, as the proportion of patients taking the drug experiencing vascular occlusion events (eg, blood clots, severe narrowing of blood vessels) was significantly greater than the proportion reported at the time of its approval in December 2012. The FDA approved revised prescribing information in the US, as well a Risk Evaluation and Mitigation Strategy (REMS), allowing for immediate resumption of marketing and commercial distribution. Changes include a revised indication statement and boxed warning, updated safety information, and recommendations regarding dosing considerations. Additional information is available here and here.

See previous story.

StemAlive 90 Capsules Recalled

01-20-2014

Stemvida is recalling 11 lots of StemAlive 90 Capsules nutritional supplement after they were found to contain undeclared milk, which can cause serious or life-threatening allergic reactions in people who have an allergy or severe sensitivity to milk. StemAlive was distributed in Arizona, California, Colorado, Florida, New Jersey, New York, Nevada, Oklahoma, Texas, and Utah.

Consumers who purchased StemAlive 90 Capsules should return them to Stemvida for replacement or refund. For more information, contact Stemvida at 1-888-950-8432, 9 AM to 8:30 PM PST.

FDA Recommends Acetaminophen 325 mg or Less Per Dosage Unit

01-15-2014

The FDA is recommending that health care providers discontinue prescribing and dispensing prescription combination drug products that contain more than acetaminophen 325 mg per tablet, capsule, or other dosage unit. There are no available data to show that taking more than acetaminophen 325 mg per dosage unit provides additional benefit that outweighs the added risks for liver injury. Limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

Over half of manufacturers voluntarily complied with the initial FDA request in January 2011 to limit the amount of acetaminophen to no more than 325 mg in each dosage unit; however, some prescription combination drug products containing more than acetaminophen 325 mg per dosage unit remain available. The FDA intends to institute proceedings to withdraw approval of prescription combination drug products with more than acetaminophen 325 mg per dosage unit that remain on the market in the near future.

The FDA recommends that a pharmacist who receives a prescription for a combination product with more than acetaminophen 325 mg per dosage unit should contact the prescriber to discuss a product with a lower dose of acetaminophen.

FDA Approves ReSure Sealant for Cataract Surgery

01-10-2014

The FDA has approved Ocular Therapeutix’s ReSure Sealant kit, the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. ReSure Sealant is approved for use in cataract surgeries on patients with clear corneas.

FDA Approves Mekinist with Tafinlar for Melanoma

01-10-2014

The FDA has approved GlaxoSmithKline’s Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma. Mekinist will be dispensed with a patient Medication Guide.

FDA Approves Generic Micardis

01-10-2014

The FDA has approved Actavis’ telmisartan 20, 40, and 80 mg immediate-release tablets, the generic version of Micardis, indicated for the treatment of hypertension and for the reduction of cardiovascular risk in patients unable to take ACE inhibitors. Actavis intends to launch the product immediately.