Browsing Tag
US FDA
379 posts
Lupin Limited has launches Tavaborole Topical Solution, 5% in US
Indian pharma company Lupin Limited has launched Tavaborole Topical Solution, 5% following regulatory approval from the US Food…
Jazz Pharmaceuticals gets Rylaze FDA approval for ALL and LBL
Rylaze FDA approval : Jazz Pharmaceuticals has secured approval for its leukemia drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn…
Lupin Limited gets FDA tentative approval for HIV drug cocktail TLD
Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new…
Unichem Laboratories gets FDA approval for Aripiprazole Tablets, USP
Unichem Laboratories said that it has secured a tentative approval for abbreviated new drug application (ANDA) of Aripiprazole…
Natco Pharma gets FDA approval for Carfilzomib Vials ANDA
Natco Pharma Limited said that its marketing partner – Breckenridge Pharmaceutical Inc. (BPI), has secured approval from the…
Alkem Laboratories gets Form 483 from US FDA for St. Louis plant
Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company…
Lupin Limited gets FDA warning letter for Lupin Somerset site
Indian pharma company Lupin Limited said that it has been issued a warning letter from the US Food…
Lupin secures FDA approval for generic Truvada, expanding HIV treatment and prevention portfolio in the US
Lupin secures US FDA approval for its generic version of Truvada, targeting HIV treatment and prevention. See what this means for the $2.1B US market.
Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic
Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets,…
Can Alembic Pharmaceuticals challenge Latuda with its FDA-approved Lurasidone Hydrochloride Tablets?
Find out how Alembic Pharmaceuticals’ FDA approval for Lurasidone Hydrochloride Tablets positions the drugmaker in the $3.7B bipolar depression market.