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Mylan Generic Imitrex Gets Tentative OK


Posted on 2006-05-30 14:51:00



Mylan Laboratories Inc. on Wednesday said it received tentative regulatory approval for three doses of its generic version of Imitrex migraine pills.

Mylan said the Food and Drug Administration tentatively approved its abbreviated new drug application for Sumatriptan Succinate in 25 milligram, 50 milligram and 100 milligram tablets.

Sumatriptan is a generic version of GlaxoSmithKline PLC's Imitrex, which had U.S. sales of $878 million in the 12 months ended March 31, according to Mylan.

A Mylan spokesman said the approval is tentative until all patents covering Glaxo's product expire. A Glaxo regulatory filing said its Sumatriptan patents are set to expire in 2006 in Europe and in 2009 in the United States.


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