Glenmark Pharmaceuticals Ltd share price gained more than two percent intraday on March 21 after its subsidiary received a final approval for Lacosamide tablets from the United States Food and Drug Administration (FDA).
"Glenmark Pharmaceuticals Inc., USA has received final approval by the USFDA for its Lacosamide tablets USP, 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," the company said in its release.
The firm plans to launch the product immediately.
“The USFDA approval for generic Lacosamide tablets USP reiterates our ongoing commitment to make treatment options more accessible for patients. We look forward to quickly launching this product in the US market," said Robert Crockart, chief commercial officer of Glenmark Pharmaceuticals.
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According to IQVIATM data for the 12 month period ending January, the Vimpat tablets clocked sales of around $1.7 billion.
Glenmark Pharmaceuticals’ 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.
Glenmark Pharmaceuticals also continues to identify and explore external development partnerships to supplement and accelerate growth of its pipeline and portfolio, the company added.
At 09:35 hours, Glenmark Pharmaceuticals was quoting at Rs 452.85, up Rs 8.95 or 2.02 percent on the BSE.
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