Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA216294 Approval for Calcitonin Salmon Injection by Amneal
The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA215856 for Furosemide Injection (10 mg/mL)
The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.
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Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Priority Approval for AstraZeneca's IMFINZI (Durvalumab) BLA761069
The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.
Regulatory Updates
Sep 18, 2026•1 min read
Ajanta Pharma’s Varenicline Tartrate Tablets Receive FDA Approval (ANDA213019)
The FDA has approved Ajanta Pharma’s oral varenicline tartrate tablets (0.5 mg and 1 mg equivalents) under ANDA213019, marking a new prescription option.
Regulatory Updates
Sep 18, 2026•1 min read
FDA approves NEXLIZET (bempedoic acid and ezetimibe) – NDA211617
The FDA approved NEXLIZET, an oral tablet combining bempedoic acid 180 mg and ezetimibe 10 mg, under NDA 211617. The approval and subsequent labeling updates are documented.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Zydus Verapamil Hydrochloride Injection (ANDA214215)
FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA076367 for Amcinonide Topical Ointment
FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA077824 for Ranitidine Tablets by Amneal Pharmaceuticals
The FDA has granted approval for ANDA077824, authorizing Amneal Pharmaceuticals’ oral ranitidine tablets in 150 mg and 300 mg strengths, now listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Minocycline Hydrochloride Tablets (ANDA 065131)
The FDA approved Strides Pharma's minocycline hydrochloride oral tablets (50 mg, 75 mg, 100 mg) under ANDA 065131, confirming prescription status.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA203834 for Acyclovir Oral Tablets
The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Jubilant Itraconazole 100 mg Capsule (ANDA203445)
FDA approved labeling for Jubilant Generics' oral itraconazole 100 mg capsule (ANDA203445); the product is listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
PRAMIPEXOLE DIHYDROCHLORIDE Extended‑Release Tablets Approved (ANDA202353)
FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.