Granules India gets USFDA approval for Metoprolol Succinate ER Tablets
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure
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.