Regulatorische Updates

FDA issued an approval letter for Bedford's ANDA078114 covering ciprofloxacin injection products (200 mg/100 mL and 400 mg/200 mL), both listed as discontinued.

The Committee on Veterinary Medicinal Products adopted a positive opinion on the marketing authorisation of Cirbloc, a vaccine for active immunisation of pigs.

The FDA has marked the oral Tolmetin tablets TOLECTIN 600 mg and TOLECTIN 200 mg as discontinued, with a record of multiple manufacturing and labeling submissions from 1979 to 1993.

The FDA has approved NDA017579 for RETIN-A, a prescription 0.025% tretinoin topical gel marketed by Bausch Health US and Mylan Pharmaceuticals.

The Ministry of Health and Welfare issued detailed guidelines on drug price ceiling re‑evaluation, setting distinct adjustment rates and grace periods for innovative and semi‑innovative pharmaceuticals.

The Korean government is reviewing a plan to extend prescription drug delivery to all telemedicine patients, prompting worries among community pharmacists about competition from large warehouse‑type pharmacies and digital platforms.

FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.

The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.

Guro‑gu Pharmaceutical Association is gathering reports of inappropriate telemedicine prescriptions from pharmacies ahead of the Dec 24 rollout to aid system improvement.

NESHER PHARMS received FDA approval (submission AP) for ANDA076640 covering Metoprolol Succinate extended‑release tablets (200 mg and 100 mg equivalents), though both products are listed as discontinued.

The FDA has approved a series of labeling submissions for generic levofloxacin tablets (250 mg, 500 mg, 750 mg) under ANDA 076361, most recently on Sep 9 2024.

Oncogenic Therapeutics received a US patent decision for Nesuparib’s high‑purity crystal form and its manufacturing process, extending protection through May 2042 ahead of US clinical trials.