Glenmark Pharma gets ANDA nod for Lacosamide Tablets USP; stock jumps ~2.5%

21 Mar 2022 , 04:28 PM

Glenmark Pharmaceuticals Inc., USA has bagged the final approval from the United States Food & Drug Administration (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 proposes to launch the product immediately.

Commenting on the development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd, said, “The FDA approval for generic Lacosamide Tablets USP reflects on our ongoing commitment to making treatment options more accessible for patients. We look forward to quickly bringing this product in the U.S. market”

Vimpat tablets, 50 mg, 100 mg, 150 mg, and 200 mg market achieved annual sales of approximately $1.7 billion* for the 12-month period ending January 2022.

Glenmark Pharma ended at Rs455 up by Rs11.1 or 2.5% from its previous closing of Rs443.90 on the BSE. It touched day’s high and low of Rs466.15 and Rs445 respectively.