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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 January 2019

  • Lurasidone Hydrochloride Tablets 20 mg, 40 mg, 60 mg, 80 mg and 120 mg
    Approved: January 3, 2019 - Amneal Pharmaceuticals LLC; InvaGen Pharmaceuticals Inc.; Lupin Pharmaceuticals, Inc.; Accord Healthcare Inc.; Torrent Pharmaceuticals Limited
    Generic for: Latuda
  • Ingenol Mebutate Topical Gel 0.015%
    Approved: January 7, 2019 - Perrigo
    Generic for: Picato Gel 0.015%
  • Ingenol Mebutate Topical Gel 0.05%
    Approved: January 9, 2019 - Perrigo
    Generic for: Picato Gel 0.05%
  • Vigabatrin Tablets 500 mg
    Approved: January 14, 2019 - Teva Pharmaceuticals USA, Inc.
    Generic for: Sabril

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Generic Drug Approvals Archive