Glenmark bags FDA approval for new generic

Glenmark Pharmaceuticals receives ANDA approval for Rufinamide Tablets USP, 200 mg and 400 mg

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Glenmark's drug is the generic version of Eisai's drug

Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for its Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg of Eisai, Inc.

With respect to 180-day generic drug exclusivity, Glenmark is said to be one of the first ANDA applicants to submit a substantially complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a paragraph IV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Rufinamide Tablets USP, 200 mg and 400 mg.

According to IMS Health sales data for the 12 month period ending March 2016, the Banzel market achieved annual sales of approximately $155.1 million.

 

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