From USFDA
Glenmark Pharmaceuticals has been granted tentative approved last week by United States Food & Drug Administration (US FDA) for its Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel Tablets of Eisai, Inc. Under the terms of settlement agreement between Glenmark and Eisai, Glenmark will be permitted to market this product in the United States on 30 May 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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