Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets

Mumbai: Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Tablets 1 USP, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat 2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc. The company plans 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 reiterates our ongoing commitment to make treatment options more accessible for patients. We look forward to quickly launching this product in the U.S. market."

According to IQVIATM sales data for the 12 month period ending January 2022, the Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg market3 achieved annual sales of approximately $1.7 billion*.

Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.