Regulatorische Updates
16. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA090353 for Senores Pharms Topiramate Tablets (Discontinued)
Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.
Regulatorische Updates
31. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA079162 for Topiramate Generic Tablets
The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.
Regulatorische Updates
25. Aug. 2026•1 Min. Lesezeit
MHRA Issues New Safety Measures: Topiramate Contraindicated in Pregnancy
Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless a Pregnancy Prevention Programme is followed, per MHRA review.