Drug Approval | November 15, 2025
Zydus receives final approval from USFDA for Leuprolide Acetate injection
Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis
Dexlansoprazole delayed-release capsules are a proton pump inhibitor
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
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