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.
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 stock price
On September 30, 2014, Glenmark Pharma closed at Rs 720.65, up Rs 3.75, or 0.52 percent. The 52-week high of the share was Rs 789.40 and the 52-week low was Rs 489.10.
The company's trailing 12-month (TTM) EPS was at Rs 15.48 per share as per the quarter ended June 2014. The stock's price-to-earnings (P/E) ratio was 46.55. The latest book value of the company is Rs 107.13 per share. At current value, the price-to-book value of the company is 6.73.
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