Regulatorische Updates

ANI PHARMS' diflorasone diacetate 0.05% topical cream (product 001) is listed as discontinued in FDA records. Multiple labeling submissions under ANDA076263 have been approved.

The FDA has approved several manufacturing (CMC) and labeling submissions for the discontinued oral suspension Mellaril‑S, containing thioridazine, under NDA 017923.

The FDA has approved a series of supplemental manufacturing (CMC) and labeling submissions for the discontinued irrigation product SODIUM CHLORIDE 0.45% in plastic containers.

The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.

South Korea’s Ministry of Health and Welfare announced faster reimbursement for Dravet syndrome treatment Fintepla‑Ac and broader coverage for blood‑cancer and pediatric‑leukemia drugs.

The Korea Anti-Doping Agency’s experiential anti‑doping education space, Fair Play Ground, celebrated its first year, having welcomed over 37,000 visitors since its August 26 opening.

839 medical institutions in Korea were found to have submitted false health‑insurance claims totaling 34.79 billion won, with clinics accounting for 42.85% of the amount.

The Ministry of Health and Welfare says expansion of medication delivery for telemedicine remains under discussion, with stakeholder input to be gathered via a public‑private council.

FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.

The FDA has approved Teva Pharmaceuticals’ generic olanzapine oral tablets (5‑20 mg) under ANDA 077243, with several labeling supplements filed since 2014.

The FDA has approved ANDA 076942 for a prescription 2% ketoconazole shampoo, marketed by Cosette Pharmaceuticals. Submission history includes labeling updates through 2020.

FDA granted priority approval to OSTEOSCAN, a technetium‑99m etidronate injectable, on Sep 28 1973; later supplemental filings updated labeling, manufacturing and efficacy. Product now discontinued.