NEW DELHI: Glenmark BSE 5.01 pct Pharmaceuticals said it has received tentative approval from the U.S. health regulator for its Lacosamide tablets.
"Glenmark Pharmaceuticals Inc U.S.A has been granted tentative approval by the United States Food and Drug Administration (USFDA) 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," the company said in a regulatory filing.
Glenmark will market this product upon receiving final approval of its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg ANDA, it added.
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, the filing said.
According to IMS Health sales data for the 12-month period ending September 2015, the Vimpat market achieved annual sales of approximately USD 691 million.
Glenmark's current portfolio consists of 102 products authorised for distribution in the U.S. marketplace and 64 ANDA's pending approval with the USFDA.
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, it said.
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