Drug Approval | November 08, 2025
Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
Sumatriptan injection is indicated in adults for the acute treatment of migraine
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
Glenmark will begin distribution in November 2025
Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients
Mesalamine suppositories are indicated for the treatment of mildly to moderately active ulcerative proctitis
Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable
Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA
Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions
Liothyronine tablets will be manufactured at Zydus' plant in Ahmedabad SEZ
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