Regulatorische Updates

The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.

The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.

The first regular Health and Welfare Committee meeting showed sharp partisan clashes, focusing on the MFDS’s responsibility linked to the Justice Minister nominee.

The National Health Insurance Labor Union criticized the government's decision to keep the 2027 health insurance contribution rate unchanged, warning it could accelerate financial deterioration amid rising medical demand.

The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.

The FDA has granted approval for an over‑the‑counter famotidine tablet (10 mg and 20 mg) under ANDA 077367, sponsored by Dr. Reddy’s Laboratories Ltd.

The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.

The FDA has listed the topical Triamcinolone Acetoinide 0.1% cream, sponsored by Morton Grove, as discontinued under ANDA 088095.

The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.

Strides Pharma filed ANDA202002 for a 5% IMIQUIMOD topical cream (product 001). The original submission was listed as approved on 24‑Jun‑2014.

The FDA has approved ANDA091665 for ARGATROBAN injection, a prescription anticoagulant submitted by PH HEALTH.

The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.