New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.
“Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets,” it 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.
It further said, “With respect to 180-day exclusivity. Glenmark was one of the first Abbreviated New Drug Application (ANDA) applicants to submit a substantially complete ANDA for Rufinamide 200 mg and 400 mg, with a paragraph IV certification. Therefore, Glenmark is eligible for 180 days of shared generic drug exclusivity for Rufinamide.”
Quoting IMS Health sales data for the 12 months to March 2016, Glenmark said Banzel tablets achieved annual sales of around $155.1 million.
The company’s portfolio consists of 113 products authorised for distribution in the US marketplace and 63 ANDA pending approvals with USFDA.
Glenmark shares were trading 1.66 per cent up at Rs 864 on BSE in the late morning session.