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Business EconomyPosted at: May 19 2016 4:39PM


Glenmark gets final USFDA nod to sell Rufinamide

Mumbai, May 19(UNI)Glenmark Pharmaceuticals said that company has received final approval from the US health regulator USFDA to sell Rufinamide.
Rufinamide is used to treat seizures caused by Lennox-Gastaut syndrome.
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., company said in a filing with BSE
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, filing added
Quoting IMS Health sales data for the 12 months to March 2016, Glenmark said Banzel tablets achieved annual sales of around USD 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.
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