Regulatory Updates
Sep 20, 2026•1 min read
MFDS to Classify GLP-1 Obesity Drugs as Potentially Abusable by September
South Korea's MFDS plans to finish designating GLP‑1 obesity treatments such as Wegovy and Mounjaro as ‘drugs with potential for abuse’ by September, requiring prescription‑only sales and mandatory labeling.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081008 for STRIFON FORTE DSC (Chlorzoxazone)
FDA approved labeling and manufacturing submissions for ANDA081008 covering the oral tablet STRIFON FORTE DSC (500 mg chlorzoxazone) by Fern Dale Labs; the product is now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Submissions for Loxapine Succinate (ANDA076762)
FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling for PLASMA‑LYTE 56 and Dextrose 5% Injection (NDA 017385)
The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Primaquine Phosphate (NDA008316)
The FDA has approved Primaquine Phosphate, an oral prescription tablet (NDA008316) from Sanofi‑Aventis U.S. LLC, with recent labeling updates in 2025.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Multiple Supplemental Submissions for Phentermine Hydrochloride (ANDA 088596)
The FDA has approved a series of supplemental labeling and manufacturing submissions for the discontinued oral tablet Phentermine Hydrochloride (37.5 mg) under ANDA 088596.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077672 for Stavudine Capsules by Aurobindo Pharma
FDA has approved labeling submissions for ANDA077672 covering stavudine oral capsules from Aurobindo Pharma; all listed products are marked discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Updates for Granisetron Injection (ANDA078564)
FDA has approved labeling supplements for ANDA078564, a discontinued Granisetron Hydrochloride injection product by Wockhardt USA, with submissions dated 2008, 2014, and 2015.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Multiple Risperidone Tablet Products under ANDA 078269
FDA has approved several oral risperidone tablet strengths ranging from 0.25 mg to 4 mg under ANDA 078269, with labeling submissions completed.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Dextrose 10% & Sodium Chloride 0.9% Injectable (Now Discontinued)
The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
MFDS to Add Stevens-Johnson Syndrome to Labels of 56 Oral Aripiprazole Products
South Korea’s MFDS will amend the approval conditions for 56 oral aripiprazole medicines, adding Stevens-Johnson syndrome as a reported adverse reaction. The change involves 12 manufacturers.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)
The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.