Glenmark Pharmaceuticals Ltd. said its US subsidiary Glenmark Generics Inc. has obtained tentative approval from US FDA for Zolmitriptan orally disintegrating tablets, its generic version of AstraZeneca's Zomig-ZMT tablets.
The tentative approval is for the 2.5 mg and 5 mg orally disintegrating tablets of Zolmitriptan and constitutes one of the first tentative approvals granted by the FDA for a generic version of the drug.
Glenmark was granted tentative approval for its immediate release version of Zolmitriptan tablets in September 2011. The company will be vertically integrated by manufacturing the active pharmaceutical ingredient for both of its Zolmitriptan products and plans to launch in May 2013 upon final approval from the US FDA.
As per IMS Health data, Zolmitriptan immediate release tablets and orally disintegrating tablets achieves sales of $131 million and $31 million, respectively, for the 12 months ended March 3012.
At the BSE, Glenmark Pharmaceuticals shares are currently trading at Rs.356.3, down 2.48 percent from the previous close.
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