規制動向

FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.

The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.

FDA records indicate the FLUTEX topical ointment (0.1% Triamcinolone Acetoinide) by IVAX PHARMS is discontinued, with original ANDA approval in 1988 and a labeling supplement in 1992.

The Korean Pharmaceutical Association has made clarifying the work scope of herbal pharmacists its top agenda, emphasizing the need to uphold the licensing principle separating pharmacists and herbal pharmacists.

FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.

FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.

The FDA approved ANDA 085208 for a 50 mg oral tablet of hydrochlorothiazide, now marked as discontinued, with supplemental manufacturing and labeling approvals spanning 1981‑2020.

FDA records show Purepac Pharm has discontinued two oral methocarbamol tablet products (500 mg and 750 mg) under ANDA 085718.

The FDA lists Technescan Gluceptate, an injectable technetium‑99m diagnostic agent by Draximage, as discontinued under NDA018272. Submission history spans 1982‑2002.

The FDA has approved TECHNESCAN HDP (NDA018321), a technetium‑99m oxidronate injection manufactured by Curium US LLC.

A policy forum at the National Assembly discussed establishing a legal basis for introducing and producing cannabis‑derived medicines to ensure stable supply for rare and intractable disease patients.

Daewoong’s Starvic and Daewon’s Potagel pediatric diarrhea suspensions are prohibited nationwide in Korea effective July 6, after MFDS found insufficient safety data for children.