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.
Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas
Intas facility at Matoda, Sanand in India (FEI 3004011473) was inspected by FDA investigators Jose E
Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets
Lupin has received correspondence from the US FDA that Lupin has addressed the concerns raised
Tarsus Pharmaceuticals Inc., in a statement announced FDA approval of Lotilaner ophthalmology solution 0.25% (XDEMVY™).
Verrica Pharmaceuticals Inc. is a dermatology therapeutics company developing medications for skin diseases requiring medical
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
