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  • FDA Drug Updates

    FDA New Approvals

    Adynovate

    Baxalta Incorporated announced that the FDA has approved Adynovate (antihemophilic factor recombinant], pegylated), an extended circulating half-life recombinant factor VIII treatment for hemophilia A. Learn more about Adynovate

    Bendeka

    Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc. announced that the FDA has approved Bendeka (bendamustine hydrochloride) injection, a liquid, low-volume (50mL) and short-time 10-minute infusion formulation of bendamustine. Bendeka is approved for the treatment of patients with chronic lymphocytic leukemia and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Teva expects to make Bendeka commercially available to prescribers during the first quarter of 2016. Learn more about Bendeka

    Cotellic

    Genentech announced that the FDA approved Cotellic (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib). Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Learn more about Cotellic

    Darzalex

    Janssen Biotech, Inc. announced the FDA has approved Darzalex (daratumumab) injection for intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. Learn more about Darzalex

    Empliciti

    Bristol-Myers Squibb Company and AbbVie announced that the FDA has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received one to three prior therapies. Learn more about Empliciti

    Fluad

    The FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older. Fluad is manufactured by Novartis Vaccines and Diagnostics Limited. Learn more about Fluad

    Kanuma

    Alexion Pharmaceuticals, Inc. announced that the FDA has approved Kanuma (sebelipase alfa) for the treatment of patients of all ages with a diagnosis of lysosomal acid lipase deficiency. Alexion is preparing to serve patients in the US with Kanuma and expects that Kanuma will become available commercially during the first week of January 2016. Learn more about Kanuma

    MyCareLink Smart Monitor

    Medtronic announced FDA approval and US commercial availability of the MyCareLink Smart Monitor, an app-based remote monitoring system for patients with implantable pacemakers. With the MyCareLink Smart Monitor, patients with a Medtronic pacemaker can use their own smartphone or tablet technology, with cellular or Wi-Fi service, to securely transmit data from their pacemakers to their physicians, who can then interpret the data to make treatment decisions. Learn more about the MyCareLink Smart Monitor

    Narcan Nasal Spray

    Adapt Pharma Limited announced that the FDA has approved Narcan (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose. Narcan Nasal Spray is expected to launch in early 2016. Learn more about Narcan Nasal Spray

    Ninlaro

    Takeda Pharmaceutical Company Limited announced that the FDA has approved Ninlaro (ixazomib) capsules, an oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ninlaro is a once-weekly pill. Learn more about Ninlaro

    Portrazza

    Eli Lilly and Company announced the FDA approval of Portrazza (necitumumab injection for intravenous use, 800mg/50mL), in combination with gemcitabine and cisplatin, for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for treatment of nonsquamous NSCLC. Learn more about Portrazza

    QuilliChew ER

    Pfizer announced that the FDA has approved QuilliChew ER (methylphenidate HCl) chewable tablets. QuilliChew ER is available in multiple dosage strengths with scored tablet options, which enable healthcare professionals to individualize the dose to meet the specific treatment needs of patients with ADHD. QuilliChew ER is expected to be available in pharmacies in the first quarter of 2016. Learn more about QuilliChew ER

    Relizorb

    Alcresta Pharmaceuticals announced that it received approval from the FDA to market Relizorb (immobilized lipase). Relizorb is a digestive enzyme cartridge designed to mimic the normal pancreatic function by breaking down fats in enteral tube feeding formula. By breaking down these fats from enteral tube feeding formulas prior to ingestion, Relizorb allows for the delivery of increased absorbable calories from fatty acids and monoglycerides to adults who are partially or completely unable to breakdown and absorb fats. Learn more about Relizorb

    Tafinlar and Mekinist

    Novartis announced that the FDA has granted regular approval for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma. Learn more about Tafinlar and Mekinist

    Tagrisso

    AstraZeneca announced that the FDA has approved Tagrisso (osimertinib) (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy. Learn more about Tagrisso

    Vonvendi

    Baxalta Incorporated announced that the FDA has approved Vonvendi (von Willebrand factor [recombinant]). Vonvendi is a recombinant treatment for adults living with von Willebrand disease. Vonvendi is expected to be broadly available in the US in late 2016. Learn more about Vonvendi

    FDA First-Time Generic Approvals

    First Generic Version of Gleevec

    Sun Pharmaceutical Industries Ltd. announced that one of its subsidiaries has received final approval from the FDA for its Abbreviated New Drug Application for a generic version of Gleevec, imatinib mesylate tablets 100mg and 400mg. These tablets are indicated for the treatment of chronic myeloid leukemia. The commercial launch of this product is scheduled for February 1, 2016. Learn more about the first generic version of Gleevec

    FDA New Indications

    BioThrax

    Emergent BioSolutions Inc. announced that the FDA approved its supplemental Biologics License Application to expand the label of BioThrax (anthrax vaccine adsorbed) to include post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended antibacterial drugs. The vaccination schedule for this new indication consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure combined with antimicrobial therapy. Learn more about BioThrax

    Crestor

    The FDA announced that it expanded approval for AstraZeneca's Crestor to include pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia to reduce total cholesterol, LDL cholesterol, and apolipoprotein B. Learn more about Crestor

    Harvoni

    Gilead Sciences, Inc. announced that the FDA has approved Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5, and 6 chronic hepatitis C virus infection and in patients coinfected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Learn more about Harvoni

    Opdivo as a Single Agent for Melanoma

    Bristol-Myers Squibb Company announced that the FDA has approved Opdivo (nivolumab) injection, for intravenous use, as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Learn more about Opdivo as a single agent for melanoma

    Opdivo for Renal Cell Carcinoma

    Bristol-Myers Squibb Company announced that the FDA has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Learn more about Opdivo for renal cell carcinoma

    Pradaxa

    Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis and pulmonary embolism in patients who have undergone hip replacement surgery. Learn more about Pradaxa

    FDA Recalls

    Compounded Multivitamins by Glades Drugs

    The FDA is alerting healthcare professionals and patients about a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (cholecalciferol), distributed nationwide by Glades Drugs. The FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Learn more about compounded multivitamins by Glades Drugs

    Digital Temple Thermometer

    Bestmed, LLC initiated a nationwide recall of the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd, featuring lot numbers S/N: 3612 through S/N: 3715, which were sold between October 2012 until the start of the recall in November 2015. Some Digital Temple Thermometers contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures, which potentially may cause the user or caregiver of the user to delay or forego seeking appropriate care (generally an over-the-counter fever reduction medication) or receive more care than appropriate, when relying solely on the temperature display on the thermometer. Learn more about the Digital Temple Thermometer

    G5 Ventilator

    The G5 Ventilator V2.00 and V2.31 may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver). This problem can occur when pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected, or when disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occur within 50 milliseconds of each other. The recalled device was distributed from March 2007 to March 2014. Learn more about the G5 Ventilator

    Inspiration LS, 5i, and 7i Ventilator Systems

    eVent Medical is recalling the LS, 5i, and 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. This recall includes all models of eVent Medical LS, 5i, and 7i Inspiration ventilators manufactured prior to January 21, 2015. Distribution dates: February 14, 2013 to December 31, 2014. Learn more about Inspiration LS, 5i, and 7i ventilator systems

    Lipo Escultura

    Lipo Escultura Corp. and JAT Natural Products Corp. are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the FDA and have been found to contain two potentially harmful ingredients—sibutramine and diclofenac. Learn more about Lipo Escultura

    Natureal

    Inaffit, LLC is voluntarily recalling all lots of Natureal light green and dark green capsules to the consumer level after FDA laboratory testing found Natureal to contain sibutramine. The affected Natureal product includes lots Manufactured 3/12/2015 Expiration Date 3/11/2017 which have been distributed from the Natureal office and nationwide to consumers via the Internet. Learn more about Natureal

    RotaWire Elite Guidewire and the wireClip Torquer Guidewire

    The RotaWire Elite Guidewire and wireClip Torquer Guidewire are components of the Rotablator Rotational Atherectomy System. The device is used to open narrowed arteries and improve blood flow to the heart by cutting plaque from the artery wall (atherectomy). Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and separate from the rest of the Rotablator Rotational Atherectomy System and cause serious injury such as tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire fragments elsewhere in the body. Learn more about the RotaWire Elite Guidewire and the wireClip Torquer Guidewire recall

    FDA Alerts

    Clozapine REMS

    Due to ongoing implementation challenges with the new Clozapine REMS program, the FDA is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that healthcare professionals have sufficient time to complete this process and that patient access to clozapine is maintained. The FDA is also carefully evaluating next steps regarding the December 14, 2015 pre-dispense authorization (PDA) launch. The FDA will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible. Learn more about Clozapine REMS

    Endoscope Washer/Disinfectors

    The FDA is recommending that healthcare facilities currently using Custom Ultrasonics automated endoscope reprocessors (AERs) transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible. As part of the FDA’s ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. Learn more about Endoscope washer/disinfectors

    Fit Firm and Fabulous Ultimate Herbal Slimcap Capsules

    Fit Firm and Fabulous is voluntarily recalling lots 05/02/2015 to 05/01/2017 of Ultimate Herbal Slimcap capsules, to the consumer level. FDA analysis has found the product to contain undeclared sibutramine. Learn more about Fit Firm and Fabulous Ultimate Herbal Slimcap capsules

    Intravascular Medical Devices

    The FDA wants to make healthcare providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (eg, peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes. Learn more about intravascular medical devices

    Iodine-containing Contrast Agents

    The FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads the FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. The FDA approved changes to the labels of all iodinated contrast media products to include information about these cases. Learn more about iodine-containing contrast agents

    OmniPod Insulin Management System

    Insulet Corporation initiated a lot-specific voluntary Field Safety Notification for 15 lots of the OmniPod that were distributed in the US and 3 lots that were distributed internationally. The notification is due to a slight increase in the reported cases in which the OmniPod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis. Learn more about the OmniPod insulin management system

    Plavix

    An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer. Learn more about Plavix

    SGLT2 Inhibitors

    An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization. As a result, the FDA added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations. The FDA is also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. Learn more about SGLT2 inhibitors