Last Updated on December 24, 2023 by The Health Master
Granules India announced that the US Food & Drug Administration (USFDA) 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 USFDA .
The current annual US market for Metoprolol Succinate ER Tablets is approximately $321 million, according to MAT Mar 2023, IQVIA/IMS Health.
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