Glenmark Pharmaceuticals receives tentative ANDA approval for Lacosamide Tablets

From US FDA

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration 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. Glenmark will market this product upon receiving final approval of its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg ANDA. The patent listed in the Orange Book for Vimpat Tablets is scheduled to expire on 17 March 2022.

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