Glenmark Gains US FDA Approval for Lacosamide Tablets

After Glenmark Pharmaceuticals announced that it has received tentative approval by the United States Food & Drug Administration (USFDA) for its Lacosamide tablets in dosages of 50mg, 100mg, 150mg and 200mg, shares of Glenmark Pharmaceuticals were up over 5% at Rs 992 on the Bombay Stock Exchange.

The tablets are the generic version of Vimpat tablets of 50mg, 100mg, 150mg and 200mg of UCB, Inc., the company said in a release. 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.

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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 authorized for distribution in the US marketplace and 64 ANDA's pending approval with the USFDA. Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Source-Medindia

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