Regulatorische Updates

The FDA has approved ANDA 076392 for Mefloquine Hydrochloride oral tablets (250 mg) manufactured by Teva Pharmaceuticals, sponsor BARR.

FDA has approved ANDA078654 submitted by SUN PHARM INDS INC for clonazepam orally disintegrating tablets across several strengths; all listed products are currently discontinued.

FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.

The FDA approved ANDA077165 for a preservative‑free granisetron hydrochloride injectable product by Dr. Reddys; the product is listed as discontinued.

GC Green Cross announced that its Hunter syndrome therapy Hunterraze IV received product approvals from India's CDSCO and Taiwan's TFDA, while the ICV formulation also secured TFDA clearance, expanding its presence in the Asian rare‑disease market.

Novo Nordisk received European Commission approval for its oral Wegovy for obese or overweight adults, positioning it ahead of Eli Lilly’s pending oral GLP‑1 drug in Europe.

The FDA approved application ANDA076576 for oral Sotalol Hydrochloride tablets (80 mg, 120 mg, 160 mg) from Sun Pharm Industries; all listed products are marked discontinued.

President Lee Jae‑myung urged ministries to swiftly approve and integrate abortion drugs into a public safety framework, with lawmakers pressing parliament for rapid action.

The FDA granted priority approval for SANOFI AVENTIS US's ORNIDYL injectable (Eflornithine Hydrochloride 200 mg/mL) under NDA019879, with orphan drug designation.

FDA approved ANDA206666 for Pentamidine Isethionate injectable, a prescription drug administered intramuscularly or intravenously.

President Lee Jae‑myung’s remarks on safe, medically supervised use of mifepristone prompted the government to revisit its approval, sending Hyundai Pharmaceutical’s shares to a limit, though experts caution approval is not guaranteed.

The Korean Health Society Pharmacy Association (건약) praised President Lee Jae‑myung’s call to swiftly introduce abortion medication and urged the government to accelerate approval processes.