Granules India Limited today, 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, the company announced through an exchange filing.
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.
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.
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
