Glenmark Pharmaceuticals gets final approval for Rufinamide Tablets

From USFDA

Glenmark Pharmaceuticals has been granted final approval by the United States Food and Drug Administration for its Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Benzel Tablets, 200 mg and 400 mg of Eisai Inc.

With this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Rufinamide Tablets USP, 200 mg and 400 mg.

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