Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves NESHER PHARMS Metoprolol Succinate ER Tablet (ANDA077176)
The FDA approved NESHER PHARMS' ANDA077176 for metoprolol succinate extended‑release tablets (50 mg eq). The product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
South Korea launches fast‑track health‑insurance listing pilot for rare disease drugs
The Ministry of Health and Welfare aims to cut the health‑insurance listing period for rare‑disease therapies from up to 240 days to within 100 days, initially covering about five drugs.
Regulatory Updates
Aug 30, 2026•1 min read
KPA Stresses Patient Safety Over Private Use in Medical Data Discussions
The Korean Pharmaceutical Association urges prioritizing secure patient‑institution data linkage rather than expanding private sector use of medical data, emphasizing safety and professional roles.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA076603 for Betamethasone Dipropionate Topical Cream
FDA lists ANDA076603 for Betamethasone dipropionate 0.05% cream by Chartwell Molecular; the product is marked discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
SUN PHARM INDS LTD Benazepril/Hydrochlorothiazide ANDA (ANDA077483) Products Discontinued
FDA records show four oral tablet products of benazepril hydrochloride and hydrochlorothiazide under ANDA077483 are discontinued, with multiple supplemental labeling approvals.
Regulatory Updates
Aug 30, 2026•1 min read
Health Canada issues alert on Pro+ model p7924a13 labeling error
The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.
Regulatory Updates
Aug 30, 2026•1 min read
Health Canada Issues Labeling Alert for Pro+ Model p7924a13
Health Canada reports that the UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatible bed frame use.
Regulatory Updates
Aug 30, 2026•1 min read
FDA approves ANDA 078079 for ciclopirox 8% topical solution
FDA issued an approval letter on Sep 25, 2007 for Teva Pharms' ANDA 078079 covering a discontinued ciclopirox 8% topical solution.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA080123 for LANTRISUL Oral Suspension
The FDA approved an ANDA (ANDA080123) for LANTRISUL oral suspension, a discontinued product containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, submitted by LANNETT.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA080711 for Procaine Hydrochloride Injection
The FDA approved ANDA080711 for a procaine hydrochloride injectable product by BEL MAR. The original submission was approved on Dec 3 1973 and the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Isoniazid Tablet (ANDA083060)
FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.
Regulatory Updates
Aug 30, 2026•1 min read
WHARTON LABS ANDA083665: Oral Vitamin A Capsule Discontinued
WHARTON LABS submitted ANDA083665 for an oral Vitamin A capsule containing vitamin A palmitate (50,000 units). The product is listed as discontinued.