FDA Approves Generic Zomig and Zomig-ZMT Tablets

May 15, 2013 -- The U.S. Food and Drug Administration today approved the first generic versions of Zomig and Zomig-ZMT tablets. Zomig (zolmitriptan) belongs to the class of drugs called triptans, and is indicated for the acute treatment of migraine with or without aura in adults.

Zomig was first approved in tablet form in November 1997, and Zomig-ZMT orally disintegrating tablets followed in February 2001 as an alternative for patients who have difficulty swallowing conventional tablets.

The generic Zolmitriptan Tablets will be available in 2.5 mg and 5 mg strengths, and Apotex Corp., Glenmark Generics and Mylan Pharmaceuticals, Inc. have indicated that distribution of their products will commence immediately.

Apotex and Glenmark will also produce Zolmitriptan Orally Disintegrating Tablets in 2.5 mg and 5 mg strengths.

According to IMS Health for the 12 month period ending December 2012, zolmitriptan products garnered annual sales of USD 176 million.

Posted: May 2013


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