規制動向

The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.

The FDA approved an ANDA for Voriconazole injection, a 10 mg/mL intravenous antifungal solution, sponsored by Hainan Poly Pharm.

Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.

The FDA approved TAZVERIK, a prescription oral tablet for EPIZYME Inc., under NDA 213400 with priority review and orphan designation.

The FDA has approved Ajanta Pharma’s oral varenicline tartrate tablets (0.5 mg and 1 mg equivalents) under ANDA213019, marking a new prescription option.

The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.

The FDA has granted approval for Zydus Lifesciences’ generic leflunomide tablets (10 mg and 20 mg) under ANDA212308.

The FDA has approved ANDA 211928 for 250 mg oral capsules of ethosuximide, manufactured by Strides Pharma Science Limited and sponsored by ONESOURCE.

The FDA approved NEXLIZET, an oral tablet combining bempedoic acid 180 mg and ezetimibe 10 mg, under NDA 211617. The approval and subsequent labeling updates are documented.

President Lee Jae‑myung indicated that abortion medication could be prescribed and dispensed in‑hospital for two years, then shift to hospital prescription with external pharmacy dispensing.

South Korea’s MFDS will amend the approval conditions for 56 oral aripiprazole medicines, adding Stevens-Johnson syndrome as a reported adverse reaction. The change involves 12 manufacturers.

한국의료분쟁조정중재원이 2025년 새로 문을 연 약국에 1만원의 손해배상금 부담금을 12월에 부과·징수한다. 폐업한 경우는 제외된다.