Glenmark Pharmaceuticals today said it has been granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.
Lennox-Gastaut syndrome is a form of childhood-onset epilepsy.
“Glenmark...has been granted tentative approval last week by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets,” the company said in a BSE filing.
The approval has been granted for the tablets in 200 mg and 400 mg strengths. Rufinamide is a therapeutic equivalent of Banzel tablets of Eisai.
Glenmark further said: “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.”
Citing IMS Health sales data, the pharma firm said: “For the 12 month period ending March, the Banzel market achieved annual sales of approximately $121.8 million.”
Glenmark’s current portfolio consists of 96 products authorised for distribution in the US marketplace and 68 ANDAs (Abbreviated New Drug Application) pending approval with the FDA.
“In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio,” the company added.
Shares of Glenmark Pharmaceuticals were trading at Rs 902.65 apiece in the morning trade, down 0.48 per cent on the BSE.