Glenmark Generics Inc, USA, the US subsidiary of Glenmark Generic, has been granted tentative approval by 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 pharma ingredient for both of its zolmitriptan products and plans to launch in May 2013 upon final approval from the US FDA.
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’s current portfolio consists of 80 products authorised for distribution in the US marketplace and 38 ANDA’s pending approval with the US FDA. The company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.
EP Bureau — Mumbai