US FDA approves Granules India’s ANDA for Metoprolol Succinate ER Tablets


Hyderabad, June 13 (UNI) FDA | 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.

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure, Granules India said in a release here.

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.

UNI CS1645


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