FDA tentatively approves Mylan's generic form of Imitrex for migraines

By Lisa Kerner

Erie, Pa., May 24 - The Food and Drug Administration granted tentative approval for Mylan Laboratories Inc.'s Abbreviated New Drug Application for Sumatriptan Succinate Tablets (25 mg, 50 mg and 100 mg (base)) for the treatment of migraine headaches.

Sumatriptan Succinate Tablets are the generic version of GlaxoSmithKline's Imitrex Tablets, which had annual U.S. sales of $878 million as of March 31, according to a company news release.

Located in Pittsburgh, Mylan develops, licenses, manufactures, markets and distributes generic and proprietary products.

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