Glenmark Pharmaceuticals Inc., USA (Glenmark) has received US FDA tentative ANDA approval for its rufinamide tablets USP, 200 mg and 400 mg.
This is therapeutic equivalent of Banzel tablets of Eisai, Inc. As per agreement between Glenmark and Eisai, Glenmark will be market this product in the US on May 30, 2022 or may be potentially earlier under certain circumstances. According to sales data for the 12 month period ending March 2015, the Banzel market got annual sales of approximately $121.8 million.
Glenmark’s current portfolio contains of 96 products authorized for distribution in the US marketplace and 68 ANDA’s pending approval with the US FDA.
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