Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Supplemental ANDA 086178 for GLYCOPYRROLATE Tablet
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.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 086865 for Chlorpropamide Tablet (Discontinued)
The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues FLUTEX Topical Ointment (ANDA087377)
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.
Regulatory Updates
Aug 30, 2026•1 min read
Korean Pharmaceutical Association Calls for Clear Definition of Herbal Pharmacist Scope
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.
Regulatory Updates
Aug 30, 2026•1 min read
FDA ANDA083061: Diphenhydramine Hydrochloride Capsules Discontinued
FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Levetiracetam Oral Solution (ANDA078976)
FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 085208 for Hydrochlorothiazide 50 mg Oral Tablet (Discontinued)
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.
Regulatory Updates
Aug 30, 2026•1 min read
Purepac Pharm Discontinues Methocarbamol Tablet Products (ANDA085718)
FDA records show Purepac Pharm has discontinued two oral methocarbamol tablet products (500 mg and 750 mg) under ANDA 085718.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Technescan Gluceptate Injection (NDA018272)
The FDA lists Technescan Gluceptate, an injectable technetium‑99m diagnostic agent by Draximage, as discontinued under NDA018272. Submission history spans 1982‑2002.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves TECHNESCAN HDP (NDA018321) for Intravenous Use
The FDA has approved TECHNESCAN HDP (NDA018321), a technetium‑99m oxidronate injection manufactured by Curium US LLC.
Regulatory Updates
Aug 30, 2026•1 min read
Korea advances legal framework for medical cannabis to aid rare disease patients
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.
Regulatory Updates
Aug 30, 2026•1 min read
South Korea bans pediatric use of Daewoong's Starvic and Daewon's Potagel suspensions
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.