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The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.

The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.

The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.

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.

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.

FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.

FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.

The FDA has granted approval for ANDA077824, authorizing Amneal Pharmaceuticals’ oral ranitidine tablets in 150 mg and 300 mg strengths, now listed as discontinued.

The FDA approved Strides Pharma's minocycline hydrochloride oral tablets (50 mg, 75 mg, 100 mg) under ANDA 065131, confirming prescription status.

The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.

FDA approved labeling for Jubilant Generics' oral itraconazole 100 mg capsule (ANDA203445); the product is listed as discontinued.

FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.