Glenmark Pharmaceuticals gets tentative approval for Lacosamide Oral Solution, 10 mg/mL

From USFDA

Glenmark Pharmaceuticals announced that Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration for its Lacosamide Oral Solution, 10mg/mL, the generic version of Vimpat Oral Solution, 10mg/mL of UCB, Inc. Glenmark will market this product upon receiving final approval of its Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Orange Book for Vimpat Oral Solution 10 mg/mL is scheduled to expire on 17 March 2022.

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