Regulatorische Updates

The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.

The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.

Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.

FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.

The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.

The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.

The FDA approved NESHER PHARMS' ANDA077176 for metoprolol succinate extended‑release tablets (50 mg eq). The product is listed as discontinued.

FDA approved ANDA077779 for metoprolol succinate extended‑release tablets from NESHER PHARMS; product listed as discontinued.

The FDA has approved the ANDA076900 for Atenolol tablets (25 mg, 50 mg, 100 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.

The FDA granted approval for ANDA076620 on Oct 15, 2004, covering three oral fosinopril sodium tablet strengths submitted by Actavis Labs, all currently listed as discontinued.