규제 업데이트

The FDA has approved a series of manufacturing and labeling submissions for Indomethacin (NDA 018858). Both listed capsule products (25 mg and 50 mg) are marked discontinued.

Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.

FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.

The FDA records show that the injectable product Wellcovorin, containing Leucovorin Calcium (50 mg per vial), has been marked as discontinued under ANDA089465.

The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.

The government plans to consolidate the Korean Rare Essential Medicines Center, the Pharmaceutical Safety Management Agency and the Vaccine Safety Technology Support Center under a new Korean Pharmaceutical Safety Agency.

The Korean MFDS flagged protocol adherence, monitoring and record‑keeping issues in the clinical trial for Dayvigofilm coating tablet, though no serious violations were found.

At a forum on sustainable healthcare, Professor Ahn Hee‑kyung highlighted bottlenecks in Korean patients’ access to innovative anticancer drugs and urged a valuation framework that includes clinical and socioeconomic benefits.

The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor PharmaFair as discontinued under ANDA 089107.

FDA records show PHARMAFAIR's topical fluocinolone acetone 0.01% solution (product 001) is marked as discontinued under ANDA088449.

The FDA approved application ANDA088119 for an oral Isoniazid 300 mg tablet marketed by Duramed Pharms Barr. The product is listed as discontinued and includes a detailed submission history.

The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.