May 16, 2012, 08.44 PM IST | Source: Moneycontrol.com

Glenmark gets tentative US nod for migraine treatment drug

Glenmark Pharma's US generics arm has received tentative approval from US Food and Drugs Administration (FDA) for Zolmitriptan orally disintegrating tablets, its copy of AstraZeneca's ZomigZMT tablets.

Moneycontrol Bureau

Glenmark Pharma 's US generics arm has received tentative approval from US Food and Drugs Administration (FDA) for Zolmitriptan orally disintegrating tablets, its copy of AstraZeneca's ZomigZMT tablets.

The drug is used to treat acute migraine attacks. The tentative approval for the 2.5 mg and 5 mg Zolmitriptan orally disintegrating tablets is one of the first granted by the US drug regulator a for a generic version of this medicine, it said.

Glenmark was granted tentative approval for immediate release version of Zolmitriptan tablets in September last year. It plans to launch the product in May 2013, upon getting final approval from the US FDA.

For the year ended March 2012, Zolmitriptan immediate release tablets, and orally disintegrating tablets had sales of USD 131 million and USD 31 million respectively, Glenmark said, citing IMS Health data.

It currently has 80 products authorized for distribution in the US and 38 ANDAs (abbreviated new drug application) pending approval with the US FDA.
 
Glenmark shares were down 2.8% at Rs 354.85 on NSE in noon trade.

Glenmark stock price

On April 16, 2014, at 13:22 hrs Glenmark Pharma was quoting at Rs 581.00, down Rs 0.35, or 0.06 percent. The 52-week high of the share was Rs 612.00 and the 52-week low was Rs 467.50.


The company's trailing 12-month (TTM) EPS was at Rs 13.53 per share as per the quarter ended December 2013. The stock's price-to-earnings (P/E) ratio was 42.94. The latest book value of the company is Rs 93.03 per share. At current value, the price-to-book value of the company is 6.25.

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