1. Glenmark share price jumps 5% on tentative USFD nod for Lacosamide Tablets

Glenmark share price jumps 5% on tentative USFD nod for Lacosamide Tablets

Glenmark Pharmaceuticals share price gained as much as 4.5 per cent in the morning trade on Friday after the company informed stock exchanges that Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the USFDA for its Lacosamide Tablets.

By: | Updated: October 30, 2015 3:54 PM
Glenmark Pharma share price

Glenmark Pharmaceuticals share price gained as much as 4.5 per cent in the morning trade on Friday after the company informed stock exchanges that Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the USFDA for its Lacosamide Tablets. (Express Photo)

Glenmark Pharmaceuticals share price jumped over 5 per cent in the morning trade on Friday after the company informed stock exchanges that Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & 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.

At 10.18 am, Glenmark Pharmaceuticals shares were trading 3.90 per cent up at Rs 982.20. The scrip opened at Rs 970 and had touched a high and low of Rs 987.55 and Rs 970, respectively, in trade so far.

Later, the scrip closed 5.01 per cent up at Rs 991.

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.

The Vimpat market achieved annual sales of approximately $691.0 million, according to IMS Health sales data for the 12 month period ending September 2015.

Glenmark’s current portfolio consists of 102 products authorised for distribution in the US 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.

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