FDAnews Drug Daily Bulletin

FDA GIVES TENTATIVE APPROVAL FOR TEVA'S GENERIC IMITREX

Dec. 11, 2006
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Teva Pharmaceutical has won tentative FDA approval to market sumatriptan succinate, a generic version of GlaxoSmithKline's (GSK) Imitrex, a drug used for the acute treatment of migraine headaches.

Teva intends to market the drug in 25-, 50- and 100-mg tablets upon final FDA approval in February 2009, when patent protection for the brand product expires, the company said.

GSK's Imitrex generated sales of approximately $910 million for the 12 months ended September 2006, according to IMS Health.