Browsing Tag
US FDA
379 posts
Strides Pharma gets FDA approval for Potassium Chloride Oral Solution generic
Strides Pharma Science has secured approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the US…
Sun Pharmaceutical gets SEZABY FDA approval for neonatal seizures
Sun Pharmaceutical Industries has secured approval for SEZABY (phenobarbital sodium powder for injection) from the US Food and…
Aurobindo Pharma announces FDA final approval for Amphotericin B Liposome for Injection
Aurobindo Pharma said that its fully-owned subsidiary — Eugia Pharma Specialities has secured final approval for Amphotericin B…
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…
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.
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…