USFDA's tentative nod for Glenmark to sell Rufinamide

Published on May 21, 2015 13:43:14 PM

US health regulator, USFDA has given a tentative nod to Glenmark Pharmaceuticals to sell Rufinamide tablets in 200 mg and 400 mg strengths.

Rufinamide is similar to Banzel tablets of Eisai, used in the treatment of seizures which are caused by Lennox-Gastaut syndrome (form of childhood-onset epilepsy).

According to the settlement agreement, Glenmark is permitted to market Rufinamide in the US on May 30, 2022 or possibly before due to certain circumstances.

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

The current Glenmark’s portfolio has 96 authorised products for distribution in US and 68 Abbreviated New Drug Application (ANDAs) are pending for FDA approval.