Browsing Tag
US Food and Drug Administration
348 posts
Alembic Pharmaceuticals secures US FDA approval for Ketorolac Tromethamine injectable as generic to Roche’s Toradol
Alembic Pharmaceuticals wins US FDA approval for Ketorolac Tromethamine injectable, a generic to Roche’s Toradol, expanding its US sterile injectables portfolio.
Glenmark Pharmaceuticals gets FDA final approval for Buphenyl generic
Glenmark Pharmaceuticals said that it has bagged final approval for Sodium Phenylbutyrate Tablets USP, 500 mg by the…
Alembic Pharmaceuticals secures FDA final approval for generic mesalamine extended-release capsules for ulcerative colitis remission
Alembic Pharmaceuticals gains US FDA approval for its generic mesalamine extended-release capsules, targeting the $133M ulcerative colitis market.
Seres Therapeutics gets FDA priority review designation for SER-109 in rCDI
Seres Therapeutics has secured priority review designation from the US Food and Drug Administration (FDA) for SER-109, its…
Zydus Lifesciences gets FDA final approval for Ofirmev generic
Zydus Lifesciences Limited (formerly Cadila Healthcare) said that it has secured final approval from the US Food and…
FDA indicates official action on Jubilant Pharmova Roorkee facility
Jubilant Pharmova said that the US Food and Drug Administration (FDA) has determined the inspection classification of its…
FDA approves Janssen’s TECVAYLI for multiple myeloma treatment
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval…
Zydus Lifesciences gets FDA final approval for Micafungin for Injection
Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Micafungin for Injection, 50 mg/vial and 100 mg/vial,…
Alembic Pharmaceuticals clears US FDA inspection at Vadodara bioequivalence facility without observations
Alembic Pharmaceuticals clears US FDA inspection at Vadodara bioequivalence facility with zero observations, strengthening its generics pipeline and regulatory track record.
Zydus Lifesciences gets FDA final approval for Toradol generic
Zydus Lifesciences Limited (previously Cadila Healthcare Limited) has secured final approval for its analgesic drug Ketorolac Tromethamine Tablets…