Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANI PHARMS' Fosinopril/HCTZ Tablets (ANDA 076608)
The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.
Regulatory Updates
Sep 10, 2026•1 min read
FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions
The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.
Regulatory Updates
Sep 10, 2026•1 min read
Korean Health Insurance Drug List Shrinks, OTC Items Decline Faster Than Prescription
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.
Regulatory Updates
Sep 10, 2026•1 min read
Korean Pharmacy Association Accelerates Emergency Committee Formation Amid Telemedicine Delivery Expansion
The Korean Pharmaceutical Association is fast‑tracking an emergency response committee to address the government’s plan to expand prescription drug delivery via telemedicine.
Regulatory Updates
Sep 10, 2026•1 min read
Government to Expand Telemedicine Drug Delivery, Calls for Safety and Liability Framework
Korea plans to broaden medication delivery for telemedicine patients, prompting calls to address safety risks and clarify liability among pharmacies, platforms and couriers.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Lists Two Discontinued Fluconazole Injection Products Under ANDA 076889
FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
CAM-METRAZINE (ANDA085320) Discontinued Oral Tablet by Chartwell Rx
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.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Issues ANDA Approval for Watson Labs' Procaineamide Hydrochloride Oral Capsule (ANDA083795)
The FDA has approved an ANDA (ANDA083795) for Watson Labs' oral capsule containing 250 mg of procaineamide hydrochloride. The product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
South Korea to Refund 3.76 trillion won for Out-of-Pocket Caps
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.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Multiple Submissions for Lidocaine Hydrochloride Injection (Discontinued Product)
The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.
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Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA080800 for Diphenhydramine Hydrochloride Oral Capsule
FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Mylan Nisoldipine Extended‑Release Tablets (ANDA 079051) – Discontinued Products
The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.