Glenmark gets final USFDA nod to sell Rufinamide
"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.
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 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 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. Glenmark shares were trading 1.66 per cent up at Rs 864 on BSE in the late morning session. Glenmark stock price On May 19, 2016, at 14:10 hrs Glenmark Pharma was quoting at Rs 862.50, up Rs 12.60, or 1.48 percent. The 52-week high of the share was Rs 1261.95 and the 52-week low was Rs 671.50. The company's trailing 12-month (TTM) EPS was at Rs 52.04 per share as per the quarter ended March 2016. The stock's price-to-earnings (P/E) ratio was 16.57. The latest book value of the company is Rs 227.59 per share. At current value, the price-to-book value of the company is 3.79.