Glenmark Pharmaceuticals Inc USA (Glenmark), has been granted tentative approval by the United States Food & Drug Administration (FDA) for its lacosamide tablets, 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.
Glenmark will market this product upon receiving final approval of its lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg ANDA. The patent listed in the Orange Book for Vimpat tablets, 50 mg, 100 mg, 150 mg and 200 mg is scheduled to expire on March 17, 2022.
Glenmark’s current portfolio consists of 102 products authorised for distribution in the US marketplace and 64 ANDA’s pending approval with the US 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.
Subscribe to PharmaTutor News Alerts by Email >>
