Browsing Tag
US Food and Drug Administration
348 posts
Granules India gets Venlafaxine ER Capsules FDA approval
Granules India has secured approval for its abbreviated new drug application (ANDA) for Venlafaxine Hydrochloride Extended-Release (ER) Capsules…
FDA committee backs approval of Sarepta Therapeutics’ SRP-9001 for DMD
Sarepta Therapeutics’ SRP-9001 (delandistrogene moxeparvovec) has received the backing of the Cellular, Tissue and Gene Therapies Advisory Committee…
Zydus Lifesciences gets FDA final approval for Sucralfate Tablets
Zydus Lifesciences has bagged final approval to manufacture and market Sucralfate Tablets USP, 1 gram from the US…
EarlyTect BCD test : Promis Diagnostics gets FDA breakthrough designation
Promis Diagnostics has secured breakthrough device designation for its non-invasive EarlyTect BCD test from the US Food and…
Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia
Teva Pharmaceuticals and MedinCell have bagged approval for UZEDY (risperidone) extended-release injectable suspension from the US Food and…
Zydus Lifesciences wins FDA final approval for Isoproterenol HCL injection
Zydus Lifesciences has secured final approval for Isoproterenol Hydrochloride (HCL) Injection USP, 0.2 mg/mL and 1 mg/5 mL…
Zydus Lifesciences bags FDA final approval for Tavaborole Topical Solution
Zydus Lifesciences has won final approval from the US Food and Drug Administration (FDA) for Tavaborole Topical Solution,…
Narcan nasal spray becomes the first OTC naloxone product approved by the FDA for opioid overdose treatment
Emergent BioSolutions’ Narcan nasal spray is now FDA-approved for over-the-counter use. Find out how this could change the fight against opioid overdoses.
Lupin bags tentative approval for Ocaliva Tablets generic in US
Lupin said that it has been issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg…
Can Lupin’s partnership with Caplin Steriles strengthen its position in the US injectable anesthetic market?
Lupin and Caplin Steriles secure FDA approval for generic Rocuronium Bromide Injection, targeting a $53M US anesthesia market segment.