Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#topiramate ×
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
31 ago 2026•1 min de lectura
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.
Actualizaciones regulatorias
25 ago 2026•1 min de lectura
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.