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Latest Generic Drug Approvals

First-Time Generics are the very first generic versions of marketed brand-name drug products to be approved by the FDA. The generic version is formulated to work in the same way as the brand-name product and provides the same clinical benefit.

See also: New Drug Approvals, New Drug Applications, Generic Drug Facts

First-Time Generic Approvals October 2018

  • Cefixime Capsules 400 mg
    Approved: October 9, 2018 - Alkem Laboratories Limited
    Generic for: Suprax Capsules
  • Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%
    Approved: October 17, 2018 - Taro Pharmaceuticals USA, Inc.
    Generic for: Epiduo Forte
  • Clobazam Tablets 10 mg and 20 mg
    Approved: October 22, 2018 - Amneal Pharmaceuticals LLC; Bionpharma Inc.; Breckenridge Pharmaceutical, Inc.; Camber Pharmaceuticals, Inc.; Sandoz Inc.; Taro Pharmaceuticals U.S.A., Inc.; Upsher-Smith Laboratories, LLC; West-Ward Pharmaceuticals Corp.; Zydus Pharmaceuticals (USA) Inc.
    Generic for: Onfi Tablets
  • Clobazam Oral Suspension 2.5 mg/mL
    Approved: October 22, 2018 - Amneal Pharmaceuticals LLC; Bionpharma Inc.; Mylan Pharmaceuticals Inc.; Upsher-Smith Laboratories, LLC; West-Ward Pharmaceuticals Corp.
    Generic for: Onfi Oral Suspension
  • Naproxen Sodium and Diphenhydramine Hydrochloride Tablets 220mg/25mg
    Approved: October 23, 2018 - Amneal Pharmaceuticals LLC
    Generic for: Aleve PM
  • Abiraterone Acetate Tablets 250 mg
    Approved: October 31, 2018 - Apotex, Inc.; Hikma Pharmaceuticals LLC; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.
    Generic for: Zytiga 250 mg

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Generic Drug Approvals Archive