規制動向

The Seoul Pharmacists Association will hold an emergency general meeting on Sept 5 to discuss expanding drug delivery for telemedicine, safety‑stock medicine changes, and the rise of warehouse pharmacies.

A policy forum on activating bio‑data utilization platforms was held on Aug 28 at the National Assembly, organized by the Korean Medical Data Association and the Korea Industry Federation Forum, with participation from lawmakers and industry leaders.

Mylan's oral capsule product containing 25 mg chlordiazepoxide hydrochloride (product 001) is listed as discontinued. The ANDA includes four manufacturing (CMC) submissions approved on June 10 1981.

The FDA has approved NDA018090 for Sodium Chloride 0.45% injectable, manufactured by ICU Medical Inc.

JoA Pharmaceutical has re‑launched its OTC digestive aid Gareo‑Aq, featuring DHBE, after completing a three‑year clinical re‑evaluation across six Korean medical centers.

South Korea's MFDS updated its GIFT fast‑track review criteria on March 28, adding patient real‑world experience to priority assessment for innovative rare‑disease therapies.

Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.

FDA approved ANDA089116 for BROMPHERIL, an oral extended-release tablet containing 6 mg dexbrompheniramine maleate and 120 mg pseudoephedrine sulfate, submitted by Copley Pharm; product is listed as discontinued.

FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.

The FDA granted approval for ANDA089479, submitted by AM THERAP, for an oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate. The product is listed as discontinued.

FDA granted labeling approvals for Torrent Pharm's discontinued Alfuzosin Hydrochloride 10 mg extended‑release tablet (ANDA 079054).

FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.