Glenmark Pharmaceuticals Gets Final US Approval For Lacosamide Tablet
NDTV
Glenmark said its current portfolio consists of 174 products authorised for distribution in the US marketplace and 45 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA.
Homegrown pharma major Glenmark Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Lacosamide tablet, indicated for prevention and control of seizures.
The approval granted by the US Food & Drug Administration (USFDA) to the company's arm Glenmark Pharmaceuticals Inc, USA, is for Lacosamide tablets of strengths 50 mg, 100 mg, 150 mg and 200 mg, Glenmark said in a statement.
These are generic versions of Vimpat tablets of the corresponding strengths of UCB, Inc.
"The company plans to launch the product immediately," it added.
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