Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva's Chlordiazepoxide Hydrochloride Generic (ANDA 084769)
The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.
Regulatory Updates
Sep 13, 2026•1 min read
South Korea’s Global Regulatory Harmonization Center Designated WHO Cooperation Center
The MFDS Global Regulatory Harmonization Center has been named the first WHO‑recognized Cooperation Center for strengthening medical product regulatory systems and training, expanding global harmonization efforts.
Regulatory Updates
Sep 13, 2026•1 min read
South Korea Opens 2026 Specialized Pharmacist Training Applications
The Korean Ministry of Health and Welfare will accept applications from Jan 1‑18 to designate 2026 specialized pharmacist training institutions, adding integrated medication management as a new specialty.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists ANDA089313 for Chorionic Gonadotropin Injection (Discontinued)
The FDA’s ANDA089313 for CHORIONIC GONADOTROPIN injection by Quad Pharm is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA 077105 for Valproic Acid Oral Syrup
FDA has approved multiple labeling supplements for the discontinued VALPROIC ACID oral syrup (ANDA 077105). Original approval dates to 2005.
Regulatory Updates
Sep 13, 2026•1 min read
Pharma Research Faces 2-Month Advertising Suspension for Rejuran Derma Hiller Por Tightening Ampoule
Pharma Research's cosmetic product 'Rejuran Derma Hiller Por Tightening Ampoule' will have its online advertising halted for two months due to potentially misleading clinical claims, per MFDS.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA 076815 for Diazepam Injectable
The FDA approved ANDA 076815 submitted by Parenta Pharms for a 5 mg/mL injectable diazepam product, currently listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Supplemental Manufacturing Submissions for Discontinued Sodium Chloride 0.45% Irrigation Solution
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.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA078902 for Paroxetine Hydrochloride Tablets
The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Zenara’s Aminocaproic Acid Injection (ANDA215374)
The FDA has granted approval for Zenara’s aminocaproic acid injectable (250 mg/mL) under ANDA215374, classified as a prescription product.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Assigns NDA 214937 for Helium Inhalation Product by Westair Gases
The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.
Regulatory Updates
Sep 12, 2026•1 min read
Laurus Labs Ltd Submits New Combination NDA 213696 to FDA
Laurus Labs Ltd filed a Type 4 New Combination NDA (213696) with the FDA, recorded as a standard priority original submission on Jan 25 2022.