Regulatorische Updates

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.

General OTC medicines that should be sold only in pharmacies were found being sold on an online smart store and delivered by courier, prompting renewed calls for tighter online drug distribution controls.

The Ministry of Health and Welfare issued appointment orders on July 16‑17, 2026, moving senior officials in health industry policy and suicide prevention.

Kang Cheong-hee, former head of Korea Public Organization Bank, will assume the chairmanship of the National Health Insurance Service on July 20, 2026 for a three‑year term.

Lawyer Baek Seon-hee of the Justice Innovation Party submitted three bills covering national security, illegal drone flights and public welfare.

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.

King Pharm's ANDA 085175 for quinidine sulfate 200 mg oral tablets is listed as discontinued by the FDA.

The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.

FDA approved ANDA090572 submitted by Tris Pharma, covering two discontinued children’s cetirizine hydrochloride oral solutions for allergy and hives relief.

The FDA approved IPCA Labs' ANDA090249 for a 500 mg oral chloroquine phosphate tablet in 2009; the product is currently listed as discontinued.

The FDA has approved ANDA078948 for a prescription oral tablet of Ibandronate Sodium 150 mg, sponsored by Apotex and manufactured by Golden State Medical Supply.

The FDA received ANDA080667 from sponsor Luitpold for a thiamine hydrochloride injectable product, listed as discontinued.