Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets

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The United States Food and Drug Administration (US FDA) has given final approval to Glenmark Pharmaceuticals Inc., USA (Glenmark) for its Lacosamide Tablets 1 USP, 50 mg, 100 mg, 150 mg, and 200 mg, the generic version of UCB, Inc.’s Vimpat 2 Tablets, 50 mg, 100 mg, 150 mg, and 200 mg. The product will be released right away, according to the business.

“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,”

Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd, said.

The VimpatTablets, 50 mg, 100 mg, 150 mg,, and 200 mg market3 generated annual sales of roughly $1.7 billion*, according to IQVIATM sales statistics for the 12 month period ending January 2022.

Glenmark’s current portfolio includes 174 medications that are approved for distribution in the United States and 45 ANDAs that are awaiting FDA approval. Glenmark continues to identify and explore external development collaborations to augment and accelerate the expansion of its existing pipeline and portfolio, in addition to these internal filings.

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