Regulatorische Updates

The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.

The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.

The number of drugs covered by Korea’s health insurance has fallen steadily, with over‑the‑counter medicines dropping 25.2% over five years—more sharply than prescription drugs.

The Korean Pharmaceutical Association is fast‑tracking an emergency response committee to address the government’s plan to expand prescription drug delivery via telemedicine.

Korea plans to broaden medication delivery for telemedicine patients, prompting calls to address safety risks and clarify liability among pharmacies, platforms and couriers.

FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.

Chartwell Rx’s oral tablet CAM-METRAZINE, containing 35 mg phendimetrazine tartrate, is listed as discontinued. The FDA ANDA record shows multiple manufacturing and labeling submissions.

The FDA has approved an ANDA (ANDA083795) for Watson Labs' oral capsule containing 250 mg of procaineamide hydrochloride. The product is listed as discontinued.

Over 2.26 million Koreans who surpassed their personal medical expense caps in 2024 will receive a total of 3.76 trillion won in refunds starting Aug 31, 2025.

The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.

FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.

The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.