FDA Approved New Drugs 2017

First-Time Generic Drug Approvals 2017

  • Effient (Prasugrel) - Mylan Pharmaceuticals
  • Brisdelle (Paroxetine) - Actavis Laboratories FL, Inc.
  • Lialda (Mesalamine) - Zydus Pharmaceuticals (USA) Inc.
  • Strattera (Atomoxetine) - Glenmark Pharmaceuticals Limited
  • Clolar (Clofarabine) - Abon Pharmaceuticals, LLC
  • Seroquel XR (Quetiapine Fumarate) - Accord Healthcare Inc.
  • Seroquel XR (Quetiapine Fumarate) - Pharmadax Inc.
  • Seroquel XR (Quetiapine Fumarate) - Par Pharmaceutical Inc.
  • Seroquel XR (Quetiapine Fumarate) - IntelliPharmaCeutics Corp.
  • Dymista (Azelastine Hydrochloride and Fluticasone Propionate) - Apotex Inc.
  • Sabril (Vigabatrin) - Par Pharmaceutical, Inc.
  • Vytorin (Ezetimibe and Simvastatin) - Impax Laboratories Inc.
  • Vytorin (Ezetimibe and Simvastatin) - Watson Laboratories, Inc.
  • Vytorin (Ezetimibe and Simvastatin) - Dr. Reddys Laboratories International SA
  • Liptruzet (Ezetimibe and Atorvastatin) - Watson Laboratories, Inc.
  • Rayos (Prednisone) - Actavis Laboratories FL Inc
  • Dexilant (Dexlansoprazole Delayed-Release) - Par Pharmaceutical Inc.
  • Tazorac and Avage (Tazarotene) - Taro Pharmaceuticals USA, Inc.
  • Rapaflo (Silodosin) - Sandoz Inc.
  • Venlafaxine Hydrochloride ER (Venlafaxine Hydrochloride) - Nostrum Laboratories, Inc.
  • Alkeran (Melphalan) - Alvogen Malta Operations Ltd.
  • Zyflo CR (Zileuton) - Pack Pharmaceuticals, LLC
  • Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate) - Lupin Inc.
  • Ella (Ulipristal Acetate) - Teva Pharmaceuticals USA, Inc.
  • Suprax (Cefixime) - Belcher Pharmaceuticals, LLC
  • Namzaric (Memantine and Donepezil Hydrochlorides) - Amneal Pharmaceuticals LLC
  • Ampyra (Dalfampridine) - Actavis Laboratories FL, Inc.
  • Ampyra (Dalfampridine) - (Aurobindo Pharma Limited)
  • Xyrem (Sodium Oxybate) - Roxane Laboratories, Inc.
  • Levetiracetam in Sodium Chloride - Aurobindo Pharma Limited



Last Updated: September 1, 2017

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