규제 업데이트

Daewoong Bio was ordered by South Korea’s MFDS to halt production of its 300 mg Icosapent Ethyl soft capsules for one month after failing to process a consumer claim per its own standards.

The agency announced expanded verification of medical narcotics to include zolpidem and revised safety standards for narcotic analgesics, promoting the changes at the KMA 2026 conference.

The FDA database shows ANDA076458 for fluoxetine hydrochloride oral solution, marketed under the brand Fluoxetine, with a discontinued status and multiple labeling submissions.

The MFDS will host a public‑private meeting on the 15th in Seoul to discuss regulatory and review processes for digital convergence medicines under the Digital Medical Device Act.

FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.

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

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.

Korea’s Central Pharmaceutical Review Committee says AstroGen’s autism‑treatment syrup lacks sufficient pre‑specified data for approval, despite recognized unmet need.

The FDA’s ANDA078545 submission by Pharmobedient lists two oral lamivudine tablets (150 mg and 300 mg) that are marked as discontinued, with an approval status dated March 5 2019.

Albozen Korea announced it will handle domestic distribution of Eurobaxom®, a prescription drug for recurrent/chronic urinary tract infections, with the marketing authorisation transfer slated for Q4 2026.

FDA has approved ANDA078898 for Zydus Pharm's oral galantamine hydrobromide tablets (4 mg, 8 mg, 12 mg) with standard labeling submissions.

FDA has approved the generic oral capsule ANAGRELIDE under ANDA076811, covering 0.5 mg and 1 mg strengths, sponsored by Novitum Pharma and manufactured by ANI Pharmaceuticals.