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On Friday, Glenmark Pharmaceuticals said that it has got tentative approval from the US health regulator for its Lacosamide tablets.
The company said in a regulatory filing that “Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration (USFDA) for its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc.”
It further added that Glenmark will be marketing this product upon receiving final approval of its Lacosamide Tablets , 50 mg, 100 mg, 150 mg, and 200 mg ANDA.
