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

June 13, 2023 08:51 pm | Updated 09:27 pm IST - HYDERABAD

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.

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