FDA approves Sage Therapeutics Zurzuvae
Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
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Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets
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EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023