Granules India announced that the USA 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 two hundred mg. It is bioequivalent to the reference listed drug product (RLD), Toprol-XL Tablets, 25 mg, 50 mg, one hundred mg and two hundred mg, of Toprol Acquisition LLC.
Metoprolol Succinate ER Tablets are indicated for the remedy of high blood pressure on the way to lower blood stress.
Granules now has a total of 57 ANDA approvals from USFDA (fifty five final approvals and a pair of tentative approvals).
The contemporary annual US market for Metoprolol Succinate ER Tablets is approximately $321Million, in line with MAT Mar 2023, IQVIA/IMS Health.
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