FDA greenlights Granules India’s Metoprolol Succinate ER tablets

Granules India Limited announced its receipt of US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) of Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg.

The approval positions Granules India more strongly within the approximately $321 million US market for this particular medication.

The approved drug is bioequivalent to Toprol-XL Tablets, 25 mg, 50 mg, 100 mg, and 200 mg, which is a reference listed drug product (RLD) under Toprol Acquisition LLC. It is primarily indicated for the treatment of hypertension, working to effectively lower blood pressure.

This approval raises Granules India’s total of ANDA approvals from the US FDA to 57, which includes 55 final approvals and 2 tentative approvals. The current US market value for Metoprolol Succinate Extended-Release Tablets, as per MAT Mar 2023, is approximately $321 million, based on data from IQVIA/IMS Health.