Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets

Glenmark Pharmaceuticals Ltd today said that it has received final approval from the United States Food and Drug Administration (FDA) for its Lacosamide tablets. Lacosamide tablets are a generic version of Vimpat tablets of UCB, Inc and the company plans to launch the product immediately.

The company in a release said, "Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) 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."

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.