USFDA Approves Granules India's Metoprolol Succinate ER Tablets

8 Aug 2023 , 02:40 PM

Granules India has received approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate ER Tablets in varying strengths: 25mg, 50mg, 100mg, and 200mg.

This approval signifies that the drug is therapeutically equivalent to the reference listed drug, Toprol-XL Extended-Release Tablets, with corresponding strengths. The reference drug is developed by Sequel Therapeutics, LLC.

Notably, Granules India had submitted two distinct ANDAs for the same product, incorporating different technologies. This successful approval marks the second instance where Granules’ Metoprolol Succinate ER tablets have been deemed therapeutically equivalent to the reference drug, Toprol-XL ER tablets.

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