Granules India gets USFDA approval for Metoprolol Succinate ER Tablets

Granules India Limited on Tuesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. 

It is bioequivalent to the reference listed drug product (RLD), Toprol-XL Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Toprol Acquisition LLC, the company informed.

According to the regulatory filing, Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.

In addition to this approval, Granules now has a total of 57 ANDA approvals from US FDA (55 final approvals and 2 tentative approvals).

The current annual U.S. market for Metoprolol Succinate ER Tablets is approximately $321Million, according to MAT Mar 2023, IQVIA/IMS Health.

Source: Media reports