Regulatorische Updates

The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.

Korean Biochem Pharm received regulatory approval for two silodosin‑rosuvastatin sustained‑release tablets, expanding Korean United Pharm’s product line.

FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.

FDA has approved Teva Pharmaceuticals' ANDA077528 for an oral capsule combining olanzapine and fluoxetine, with several dosage strengths, as of Feb 26 2021.

The FDA authorized Celcuity's small‑molecule inhibitor Revtorpyk (gedatolisib) for hormone‑receptor‑positive, HER2‑negative breast cancer without PIK3CA mutations, to be used with fulvestrant and optionally Ibrance.

The FDA has approved the Padcev and Keytruda combination as the first muscle‑invasive bladder cancer therapy usable irrespective of cisplatin eligibility, for both neoadjuvant and adjuvant settings.

South Korea's MFDS has drafted an amendment to approval conditions for 134 dapagliflozin‑metformin combination drugs, seeking public comments to unify efficacy, dosage and safety guidance.