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Glenmark Pharma’s arm receives USFDA’s final approval for Lacosamide Tablets

21 Mar 2022 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- 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 2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc. The company plans to launch the product immediately.

According to IQVIA sales data for the 12 month period ending January 2022, the Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg market 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.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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