Regulatorische Updates

The FDA approved NESHER PHARMS' ANDA077176 for metoprolol succinate extended‑release tablets (50 mg eq). The product is listed as discontinued.

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.

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.

FDA lists ANDA076603 for Betamethasone dipropionate 0.05% cream by Chartwell Molecular; the product is marked discontinued.

FDA records show four oral tablet products of benazepril hydrochloride and hydrochlorothiazide under ANDA077483 are discontinued, with multiple supplemental labeling approvals.

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.

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.

FDA issued an approval letter on Sep 25, 2007 for Teva Pharms' ANDA 078079 covering a discontinued ciclopirox 8% topical solution.

The FDA approved an ANDA (ANDA080123) for LANTRISUL oral suspension, a discontinued product containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, submitted by LANNETT.

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.

FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.

WHARTON LABS submitted ANDA083665 for an oral Vitamin A capsule containing vitamin A palmitate (50,000 units). The product is listed as discontinued.