U. S. FDA nod for Granules’ copy of hypertension drug

The product is bioequivalent to Toprol-XL Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Toprol Acquisition LLC, the reference listed drug

The U.S. Food and Drug Administration (U.S. FDA) has approved Granules India’s abbreviated new drug application for hypertension drug Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg.

The product is bioequivalent to Toprol-XL Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Toprol Acquisition LLC, the reference listed drug.

Metoprolol Succinate ER tablets are indicated to lower blood pressure and their annual U.S. market is about $321 million, Granules said citing MAT March 2023 IQVIA/IMS Health numbers. The company now has 57 ANDA approvals from U.S. FDA (55 final approvals and two tentative approvals. On Tuesday, Granules shares closed 2.26% higher at ₹285.55 each on the BSE.