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  • FDA Drug Updates

    FDA New Approvals


    BioDelivery Sciences International, Inc. (BDSI) received approval for Bunavail (buprenorphine and naloxone) buccal film (CIII) from the FDA. Bunavail is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Bunavail is the first and only formulation of buprenorphine and naloxone for buccal administration. BDSI expects to launch Bunavail late in the third quarter of 2014.
    For more information, visit: http://bdsi.investorroom.com/2014-06-09-BioDelivery-Sciences-Receives-FDA-Approval-for-BUNAVAIL-buprenorphine-and-naloxone-Buccal-Film-for-the-Maintenance-Treatment-of-Opioid-Dependence


    The FDA has approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections. Dalvance is intended to treat acute bacterial skin and skin structure infections caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously. Dalvance is the first drug designated as a Qualified Infectious Disease Product to receive FDA approval. Dalvance is marketed by Durata Therapeutics.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398724.htm


    The FDA has approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. Eloctate is the first hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. Eloctate is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis). Eloctate is manufactured by Biogen Idec, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm400167.htm


    The FDA has approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn's disease. Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response. Entyvio is an integrin receptor antagonist. Entyvio is marketed by Takeda Pharmaceuticals America, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398065.htm


    AstraZeneca announced that the FDA has approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL). Epanova is the first FDA-approved prescription omega-3 in free fatty acid form. The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules) once a day, with or without food.
    For more information, visit: www.astrazeneca-us.com/media/press-releases/Article/20140506-epanova-press-release


    Valeant Pharmaceuticals International, Inc. announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the FDA has approved the New Drug Application for Jublia (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails.
    For more information, visit: http://valeant.q4web.com/investor-relations/news-releases/news-release-details/2014/Valeant-Pharmaceuticals-Announces-FDA-Approval-Of-Jublia-for-the-Treatment-of-Onychomycosis/default.aspx


    Trimel Pharmaceuticals Corporation announced that the FDA has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator thereby minimizing the risk of secondary exposure to testosterone of women or children.
    For more information, visit: http://trimelpharmaceuticals.com/News/ID/117/Trimel-Receives-FDA-Approval-for-Natesto-Nasal-Gel-to-Treat-Men-with-Low-Testosterone


    Omeros Corporation has announced that the FDA has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain. With FDA approval of Omidria, Omeros is completing preparations for a late summer/early fall 2014 U.S. product launch.
    For more information, visit: http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-newsArticle_Print&ID=1936166&highlight

    Qvar with Dose Counter

    Teva Pharmaceutical Industries Ltd. has announced that the FDA has approved the use of Qvar (beclomethasone dipropionate HFA) with a dose counter for the ongoing treatment of asthma as a preventative therapy in patients five years of age and older. The dose counter is designed to help asthma patients, as well as their caregivers, keep track of the number of doses remaining in the canister. The new product will be commercially available later this year.
    For more information, visit: www.tevapharm.com/Media/News/Pages/2014/1933984.aspx?year=2014


    Amgen announced that the FDA has approved Vectibix (panitumumab) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer. The FDA also approved the therascreen KRAS RGQ PCR Kit developed by QIAGEN (therascreen KRAS test) as a companion diagnostic for Vectibix.
    For more information, visit: www.amgen.com/media/media_pr_detail.jsp?year=2014&releaseID=1934128


    The FDA has approved 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 is the first in a new class of drug, called a protease-activated receptor-1 antagonist. Zontivity must not be used in people who have had a stroke, transient ischemic attack, or bleeding in the head, because the risk of bleeding in the head is too great. Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm396585.htm

    FDA First-Time Generic Approvals

    Azelastine Hydrochloride Nasal Spray 0.15%

    Perrigo Company plc announced that it has received final approval from the FDA on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray 0.15%, a generic version of Astepro Nasal Spray. The ANDA involved contributions from both Perrigo and Impax Laboratories, Inc., who will share certain costs and benefits of this product.
    For more information, visit: http://perrigo.investorroom.com/2014-05-12-Perrigo-Company-plc-Announces-FDA-Approval-Of-Generic-Version-Of-Astepro-Nasal-Spray

    Celecoxib Capsules

    The FDA has approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50mg, 100mg, 200mg, and 400mg strengths, and has 180-day exclusivity on the 100mg, 200mg, and 400mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50mg celecoxib capsules.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399428.htm

    FDA New Indications


    Eisai Inc. and Helsinn Group announced the FDA approval of Aloxi (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children 1 month to less than 17 years of age. This is the first approval of a product for acute chemotherapy-induced nausea and vomiting prevention in patients 1 month to 6 months of age.
    For more information, visit: http://eisai.mediaroom.com/2014-05-28-FDA-Approves-ALOXI-palonosetron-HCl-to-Prevent-Nausea-and-Vomiting-due-to-Chemotherapy-in-Children-as-Young-as-1-Month


    Teva Pharmaceutical Industries Ltd. announced the FDA has expanded the indication for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa to now include adjunct to dopamine agonists. The new indication reflects that Azilect can be used alone or in combination with other Parkinson’s disease medications.
    For more information, visit: www.tevapharm.com/Media/News/Pages/2014/1938203.aspx

    Kogenate FS

    Bayer HealthCare announced that the FDA has approved a new indication for Bayer’s Kogenate FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
    For more information, visit: http://pharma.bayer.com/html/pdf/KN2800013_FINAL_US_FDA_Approval_for_Secondary_Prophylaxis_for_Kogenate_05_09_2014_2.pdf

    FDA Recalls

    ABACUS TPN Calculation Software

    The FDA has notified health professionals of a Class I Recall due to software failures when using ABACUS TPN calculation software. If any of these failures were to occur, patients may be at risk for toxic or overdose symptoms. The affected software was manufactured from May 17, 2006 through May 28, 2013 and distributed from May 17, 2006 through March 17, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398509.htm

    Alaris Pump Module (Model 8100), Version 9.1.18 Software

    CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. This issue does not impact the “Delay For” option. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. The affected products were manufactured from February 6, 2014 to April 8, 2014 and distributed from February 7, 2014 through April 7, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398226.htm

    Alere INRatio2 PT/INR Professional Test Strips

    Alere is recalling Alere INRatio2 PT/INR Professional Test Strips due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm396324.htm

    Dobutamine Injection (250mg/20mL)

    Hospira, Inc. issued a nationwide recall to the user level for one lot of Dobutamine Injection, USP, 250mg, 20mL, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through September 2013. The recall was due to a confirmed customer report of discolored solution. Upon review of the complaint, a chip in the glass at the neck of the vial was identified as well as glass particulate within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397449.htm

    Labetalol Hydrochloride Injection 100mg/20mL (5mg/mL), 20mL, Multidose Vial

    Hospira, Inc. will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100mg/20mL (5mg/mL) 20mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. The recall is due to embedded particulate within the glass vial and visible particles floating in the solution. The recalled lot was distributed nationwide in the U.S. in February 2014, to wholesalers/distributors, hospitals and clinics.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397775.htm

    NaturaLyte Liquid Bicarbonate Concentrate

    Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). The affected lots are being recalled because they may develop higher bacteria levels than allowed by the company’s internal specification during their shelf life.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398553.htm

    Soliris Concentrated Solution for IV Infusion

    Alexion Pharmaceuticals, Inc. announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30mL concentrated solution for intravenous infusion. The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A, and 10008A. As product from the identified lots was last shipped on October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm399536.htm

    System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps

    In March 2014, Datascope Corp/MAQUET initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part Numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx, and 0998-UC-0479Hxx), and CS300 (Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names for a potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. An IABP shutdown could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain. Between January 1, 2003 and June 30, 2011, specific System 98/98XT, CS100/CS100i, and CS300 IABPs were manufactured with an affected fan assembly, or may have received an affected fan assembly during an upgrade/service of the IABP in the field.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm396821.htm

    FDA Alerts


    The FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. The FDA recommends a decreased starting dose of Lunesta to 1mg at bedtime. The FDA approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397536.htm


    The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The study found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major GI bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm