Granules India 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 now has a total of 57 ANDA approvals from US FDA .
The current annual US market for Metoprolol Succinate ER Tablets is approximately $321 million, according to MAT Mar 2023, IQVIA/IMS Health.