• PDR Search

    Required field
  • Advertisement
  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy. Akynzeo is distributed and marketed by Eisai Inc., under license from Helsinn Healthcare S.A.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418375.htm


    Takeda Pharmaceuticals U.S.A., Inc. and Orexigen Therapeutics, Inc. jointly announced that the FDA has approved Contrave (naltrexone HCI and bupropion HCI) extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Takeda is planning to commercially launch Contrave in the fall of 2014.
    For more information, visit: ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1966361


    The FDA approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. Harvoni and Sovaldi are marketed by Gilead.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm


    Baxter International Inc. and Halozyme Therapeutics, Inc. announced that the FDA approved Baxter's subcutaneous treatment for adult patients with primary immunodeficiency (PI), Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]. Hyqvia is approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of immune globulin. Baxter expects to launch Hyqvia in the U.S. in the coming weeks.
    For more information, visit: www.baxter.com/press_room/press_releases/2014/09_12_14_hyqvia.html


    Alimera Sciences, Inc. announced that the FDA has approved Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Alimera currently intends to begin selling Iluvien in the U.S. in the first quarter of 2015.
    For more information, visit: investor.alimerasciences.com/releasedetail.cfm?ReleaseID=873291


    The FDA approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound images of the heart (echocardiograms) are hard to see with ultrasound waves. Lumason is a contrast agent made up of gas-filled microbubbles (or microspheres) that reflect the sound waves to enhance the image. Lumason helps a physician see a patient’s heart more clearly, allowing for clearer imaging of the left ventricle chamber and the smooth edge on the inside of the chambers of the heart, known as the endocardium. Lumason is marketed by Bracco Diagnostics Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418509.htm

    Lutonix DCB

    The FDA approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to reopen arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease. The Lutonix DCB is a percutaneous transluminal angioplasty catheter that has a balloon that is used to reopen the artery. The balloon is coated on its outer surface with the drug paclitaxel, which may help to prevent recurrent narrowing of arteries (restenosis) after the procedure. Lutonix DCB is manufactured by Lutonix, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418455.htm


    AstraZeneca announced that the FDA approved Movantik (naloxegol) tablets C-II as a once-daily oral peripherally acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain. Movantik is expected to be available to patients in the first half of 2015.
    For more information, visit: www.astrazeneca.com/Media/Press-releases/Article/20140916--fda-approves-movantik-tablets


    Celgene Corporation announced that the FDA has approved Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4, for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
    For more information, visit: ir.celgene.com/releasedetail.cfm?ReleaseID=872240


    Baxter International Inc. announced that the FDA has approved Rixubis [Coagulation Factor IX (Recombinant)] for routine prophylactic treatment, control, and prevention of bleeding episodes, and perioperative management in children with hemophilia B.
    For more information, visit: www.baxter.com/press_room/press_releases/2014/09_15_14_rixubis.html

    Spiriva Respimat

    Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients. Boehringer Ingelheim anticipates Spiriva Respimat to be available in January 2015.
    For more information, visit: us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2014/09-25-14-boehringer-ingelheim-announces-fda-approval-spiriva-respimat-tiotropium-bromide-inhalation-spray-maintenance-treatment-copd.html

    T2Candida Panel and T2Dx Instrument

    The FDA has allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata, and/or Candida krusei. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours. T2Candida is manufactured by T2 Biosystems, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm415728.htm


    Trulicity (dulaglutide), approved by the FDA, is the latest Eli Lilly and Company treatment option for adults with type 2 diabetes. Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Lilly plans to make Trulicity 0.75mg and 1.5mg single-dose pens available for adults in the U.S. later this year.
    For more information, visit: investor.lilly.com/releasedetail.cfm?ReleaseID=871658

    FDA New Indications


    Silvergate Pharmaceuticals, Inc. announced that the FDA approved Epaned (enalapril maleate powder for oral solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunction (to decrease the rate of development of overt heart failure and to reduce hospitalization for heart failure). These indications are in addition to the prior approval for hypertension in patients older than 1 month.
    For more information, visit: www.silvergatepharma.com/fda-approves-2-new-indications-epaned-first-enalapril-powder-oral-solution/


    Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Eylea (aflibercept) Injection for the treatment of macular edema following retinal vein occlusion, which includes macular edema following branch retinal vein occlusion in addition to the previously approved indication of macular edema following central retinal vein occlusion. The recommended dosage of Eylea in patients with macular edema following retinal vein occlusion is 2mg every month (4 weeks).
    For more information, visit: files.shareholder.com/downloads/REGN/3376854422x0x785011/289c9a9e-a261-4750-bbeb-6417a3510b5e/REGN_News_2014_10_6_General_Releases.pdf


    AbbVie announced that the FDA has approved the extension of the Humira indication for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients ages 2 and older. Humira was approved in the U.S. in 2008 for polyarticular JIA in patients ages 4 and older.
    For more information, visit: abbvie.mediaroom.com/2014-10-06-AbbVies-HUMIRA-adalimumab-Receives-U-S-FDA-Approval-for-Extension-of-Polyarticular-Juvenile-Idiopathic-Arthritis-Indication-to-Patients-Ages-2-and-Older


    Sanofi Pasteur announced that the FDA approved use of Menactra for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.
    For more information, visit: sanofipasteurus.mediaroom.com/2014-09-08-FDA-Approves-Use-of-Menactra-Vaccine-for-Booster-Immunization-Against-Potentially-Deadly-Disease

    Nova StatStrip Glucose Hospital Meter System

    The FDA has cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April of 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use with critically ill patients.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm


    Allergan, Inc., announced that the FDA has approved Ozurdex (dexamethasone intravitreal implant) 0.7mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME). Ozurdex was originally approved in June as a treatment for DME in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Based on ongoing review of clinical data demonstrating efficacy and safety, the FDA has now approved Ozurdex for use in the general DME patient population.
    For more information, visit: agn.client.shareholder.com/releasedetail.cfm?ReleaseID=873473


    Salix Pharmaceuticals, Ltd. and Progenics Pharmaceuticals, Inc. announced that the FDA has approved Relistor (methylnaltrexone bromide) Subcutaneous Injection, 12mg/0.6mL, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain. Relistor Subcutaneous Injection was approved in the U.S. in 2008 for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
    For more information, visit: news.salix.com/press-release/fda-approves-relistor-subcutaneous-injection-treatment-opioid-induced-constipation


    VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. announced that the FDA has approved a supplemental new drug application for Stendra (avanafil). Stendra is now the only FDA-approved erectile dysfunction medication indicated to be taken as early as approximately 15 minutes before sexual activity.
    For more information, visit: ir.vivus.com/releasedetail.cfm?ReleaseID=871460


    Medivation, Inc. and Astellas Pharma Inc. announced that the FDA approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). The FDA initially approved Xtandi, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves Xtandi for use in men with metastatic CRPC who have not received chemotherapy.
    For more information, visit: newsroom.astellas.us/index.php?s=31393&item=137065

    FDA New Formulations

    Abilify Maintena

    Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck announced that the FDA has approved a new formulation of Abilify Maintena (aripiprazole) for extended-release injectable suspension—a pre-filled dual-chamber syringe. Abilify Maintena is an atypical antipsychotic indicated for the treatment of schizophrenia. The companies expect the dual-chamber syringe will be available in the U.S. in January 2015.
    For more information, visit: www.otsuka-us.com/newsroom/Pages/NewsArticle.aspx?ItemId=10

    FDA Recalls

    Axilla Application of the SAM Junctional Tourniquet

    SAM Medical Products announced that it has begun notifying customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT). The company discovered through customer feedback and subsequent additional internal testing that a very low percentage of the clips in question failed during repetitive use in training. If this piece were to fail in actual use, the operator may face a potential delay in using the SJT in the Axilla area.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm417940.htm

    Heparin Sodium, 1000 USP Heparin Units/500mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500mL

    Hospira, Inc. announced a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1000 USP Heparin Units/500mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container. The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm414212.htm

    Hudson RCI Pediatric Anesthesia Breathing Circuits

    On September 8, 2014, Teleflex Medical sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken. The ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately. The affected devices were manufactured between March 2013 and July 2014, and distributed between June 2013 and May 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417868.htm

    Ketorolac Tromethamine Injection, USP, 30mg/mL

    Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024, and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product. The lot numbers being recalled were distributed to hospitals, wholesalers, and distributors nationwide from September 17, 2014 through October 1, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417445.htm

    Pharmacy Creations: Certain Products

    Pharmacy Creations has voluntarily recalled four product lots following testing results conducted that indicated that the product lots may have the potential of not being sterile. The prescription 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.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm413052.htm

    Playtex Nurser Deluxe Double Electric Breast Pump

    Playtex Manufacturing, Inc. announced a voluntary nationwide recall of certain AC/DC power adapters that are used with the Playtex Nurser Deluxe Double Electric Breast Pump. The casing on some adapters may become loose and separate, resulting in a potential for electric shock. The affected adapters were manufactured from November 2012 through July 2013. The product can be identified by product serial number (P12324-XXXX through P13205-XXXX). Alternatively, the product can be identified by adapter production code (1241 through 1324). The adapters were sold along with the Playtex Nurser Deluxe Double Electric Breast Pump. The adapters were not sold separately.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389608.htm

    Potassium Chloride Injection

    Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot # P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80mg in 100mL, product code 2B0862. As both products are packaged in 100mL containers and have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. The affected lot of Potassium Chloride Injection was distributed to customers in the U.S. between May 26, 2014, and August 8, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm414957.htm

    Vancomycin Hydrochloride for Injection, USP, Equivalent to 1g Vancomycin (Sterile Powder)

    Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015. This action is because the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm418028.htm

    FDA Alerts

    Bo Ying Compound

    FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd., due to the potential lead poisoning risk associated with the product. The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions, including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English. FDA learned of this risk from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain high levels of lead. FDA has received one adverse event report of lead poisoning in an 18-month-old child who was given this product.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm416441.htm

    Downing Labs/NuVision Pharmacy Sterile Products

    The FDA is reminding healthcare professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Healthcare professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. The FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413506.htm


    An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm416408.htm