The United States Food and Drug Administration (FDA) has granted tentative approval for Glenmark Generics Inc's (GGI), a US based subsidiary of Glenmark Pharmaceuticals Ltd, zolmitriptan orally disintegrating tablets, the 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 consitutes one of the first tentative approvals granted by the FDA for a generic vesion of the drug.

Glenamark was granted tentative approval for its immediate release version 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.

According to IMS Health for the 12 month period ending March 2012,  zolmitriptan immediate release tablets and orally disintegrating tablets achieved sales of US$ 131 million and US$ 31 million, respectively.

Glenmark Generics current portfolio consists of 80 generic products authorised for distribution in the US market and 38 ANDA's filed with the US FDA pending approval. The company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submission.