Regulatory Updates
Sep 24, 2026•1 min read
Chartwell Rx Receives FDA Approval for TRAVOPROST Ophthalmic Solution (ANDA091340)
The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 078338 for Clotrimazole 1% Topical Cream
The FDA has approved ANDA 078338 for a prescription 1% clotrimazole topical cream marketed by Fougera Pharmas.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Mylan Sumatriptan Succinate Tablets (ANDA 077744)
The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.
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 ANDA077941 for Injectable Furosemide (10 mg/mL) by Apotex
The FDA has granted approval (ANDA077941) for Apotex's injectable furosemide 10 mg/mL, classified as a prescription product.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA088262 for Imipramine Hydrochloride Tablets by Strides Pharma
The FDA has approved the ANDA for Imipramine Hydrochloride 25 mg oral tablets (brand name IMIPRAMINE HYDROCHLORIDE) manufactured by Strides Pharma Science Limited, with the latest labeling approval on May 1 2023.
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 18, 2026•1 min read
FDA Approves Zydus Lifesciences’ Generic Leflunomide Tablets (ANDA212308)
The FDA has granted approval for Zydus Lifesciences’ generic leflunomide tablets (10 mg and 20 mg) under ANDA212308.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Approval for Ethosuximide 250 mg Oral Capsules (ANDA 211928)
The FDA has approved ANDA 211928 for 250 mg oral capsules of ethosuximide, manufactured by Strides Pharma Science Limited and sponsored by ONESOURCE.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Grants ANDA Approval for ICATIBANT (ANDA213773)
FDA approved ANDA213773 for the subcutaneous injectable prescription drug ICATIBANT, manufactured by Alembic Pharmaceuticals.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Alembic’s Tretinoin 0.05% Topical Cream (ANDA214590)
The FDA has granted approval for Alembic’s prescription tretinoin 0.05% cream, submitted under ANDA214590.
Regulatory Updates
Sep 13, 2026•1 min read
Fougera Pharms Receives FDA Approval for CALCIPOTRIENE Topical Solution (ANDA 078305)
The FDA has approved Fougera Pharms' CALCIPOTRIENE 0.005% topical solution under ANDA 078305, a new prescription product.