Browsing Tag
US Food and Drug Administration
333 posts
Zydus Lifesciences gets FDA final approval for BP drug generic version
Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Bisoprolol Fumarate and Hydrochlorothiazide tablets USP, 2.5 mg/6.25…
Lupin Limited secures US FDA tentative approval for generic version of rosacea drug Oracea
Lupin Limited gains US FDA tentative approval for generic Oracea, targeting the $215M rosacea drug market in the US.
Sensorion OTOF-GT gene therapy candidate gets FDA rare pediatric designation
Sensorion, a French biotechnology company, has received the rare pediatric disease designation from the US Food and Drug…
Zydus Lifesciences gets FDA EIR with VAI for Moraiya formulations plant
Zydus Lifesciences said that the US Food and Drug Administration (FDA) has issued an establishment inspection report (EIR)…
Lupin secures US FDA tentative approval for generic version of Slynd contraceptive tablets
Lupin wins US FDA tentative approval for generic drospirenone contraceptive, targeting a $141M US market. See how this move fits its women’s health strategy.
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…