USFDA approves Glenmark’s Rufinamide drug

Glenmark Pharmaceuticals Ltd, the research-led global integrated pharma company, has announced on Thursday that it has got the approval from the US Food & Drug Administration (USFDA) for selling its Rufinamide tablets. 

The approved Abbreviated New Drug Application (ANDA) is a therapeutic equivalent of Banzel Tablets manufactured by Eisai. 

The company said in a statement that it has received final nod for manufacturing and marketing 200 mg and 400 mg Rufinamide tablets. 

The statement further said that with regards to 180-day exclusivity, Glenmark was among the firsts in the list of ANDA applicants to file a considerably complete ANDA for Rufinamide’s 400 mg and 200 mg strengths. Therefore, it is entitled to 180 days of shared generic drug exclusivity for the drug - Rufinamide. 

Rufinamide tablet is used in the treatment of seizures, which are caused by Lennox-Gastaut syndrome. 

According to IMS health’s sales data for one year ending March 2016, Banzel tablets had recorded annual sales of around $155.1 million (about Rs.1032 crore). 

Glenmark Pharmaceuticals has 113 products in its portfolio that are approved for selling in the US market and approvals on 63 ANDA are pending with USFDA. 

Glenmark’s consolidated revenue was Rs.23,066.76 million during the fourth quarter ended March 31, 2016, as against Rs.17,758.13 million in the previous corresponding quarter, witnessing a growth of 29.89 percent.