Glenmark's Rufinamide Tablets receive FDA approval

Glenmark Pharmaceuticals receives tentative ANDA approval for Rufinamide Tablets USP

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Rufinamide is a therapeutic equivalent of Banzel Tablets of Eisai

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food and Drug Administration (US FDA) for its Rufinamide Tablets USP, 200 mg and 400 mg. The drug is used to treat seizures caused by the Lennox-Gastaut syndrome.

It is a therapeutic equivalent of Banzel Tablets, manufactured by Eisai. Under the terms of a settlement agreement between Glenmark and Eisai, Glenmark will be permitted to market this product in the United States on May 30, 2022 or potentially earlier under certain circumstances.

According to IMS Health sales data for the 12 month period ending March 2015, the Banzel market achieved annual sales of approximately $121.8 million.

 

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