Glenmark Pharmaceuticals today said it has received tentative approval from the US health regulator for generic Zolmitriptan tablets used for treating migraines.
Glenmark Generics Inc, the US arm of Glenmark Generic has received tentative approval from United States Food and Drug Administration (USFDA) for zolmitriptan orally disintegrating tablets, Glenmark Pharmaceuticals said in a statement.
The approval is for zolmitriptan tablets in the strengths of 2.5 mg and 5 mg, Glenmark said.
The tablets are generic version of AstraZeneca's Zomig-ZMT tablets, it added.
Earlier in in September 2011, the company had received tentative approval for immediate release version of zolmitriptan tablets.
"According to IMS Health for the 12 month period ending March 2012, zolmitriptan immediate release tablets and orally disintegrating tablets achieved sales of $131 million and $31 million respectively," Glenmark said.
The company's current portfolio consists of 80 products authorised for distribution in the US and 38 abbreviated new drug applications (ANDA's) pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were today trading at Rs 355 in the afternoon trade on BSE, down 2.83% from its previous close.