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The US health regulator USFDA has provided its final approval to the Glenmark Pharmaceuticals for selling Rufinamide which is used to treat seizures caused by Lennox-Gastaut syndrome.
It said in a BSE filing that “Glenmark Pharmaceuticals, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets.”
The approval is granted for the tablets in 200 mg and 400 mg strengths. Rufinamide is a therapeutic equivalent of Banzel tablets to Eisai.
“With respect to 180-day exclusivity… Glenmark was one of the first 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, ” it added.
