Glenmark gets tentative US FDA nod for epilepsy drug Rufinamide

Glenmark Pharmaceuticals Inc has been granted tentative approval by the US Food & Drug Administration (US FDA) for its Rufinamide tablets USP 200 mg and 400 mg – a therapeutic equivalent of Banzel tablets of Eisai Inc. Rufinamide tablet is used to treat seizures caused by Lennox-Gastaut syndrome, which is a form of childhood-onset epilepsy.
 
Under the terms of a settlement agreement between Glenmark and Eisai, Glenmark will be permitted to market this product in the US on May 30, 2022 or potentially earlier under certain circumstances, said Glenmark in a press release.
 
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.