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The US health regulator has given its tentative approval to Glenmark Pharmaceuticals for its generic version of Vimpat Oral Solution that is used in treatment of epilepsy.
It said in a BSE filing that “Glenmark Pharmaceuticals Inc, USA has been granted tentative approval by the US Food and Drug Administration (USFDA) for its Lacosamide Oral solution, 10 Mg/mL, the generic version of Vimpat Oral Solution, 10 Mg/mL of UCB, Inc.”
This product will be marketed by the company upon receiving final approval of Lacosamide Oral solution, 10 Mg/mL.
It further said that “The patent listed in the Orange Book for Vimpat Oral Solution, 10 Mg/mL is scheduled to expire on March 17, 2022.”
