FDA gives tentative approval to Aurobindo for generic Imitrex

MUMBAI, India Aurobindo Pharma has received tentative approval from the Food and Drug Administration to market and sell sumatriptan succinate tablets, a generic version of GlaxoSmithKline’s migraine drug Imitrex, according to published reports.

The first patent for the generic version expired on June 28, 2007, but there have been lawsuits and settlements between GSK and several generic companies over the drug.

Last month, Ranbaxy Laboratories said it settled its litigation with GSK and will exclusively sell generic sumatriptan for 180 days in the U.S., starting December 2008. Aurobindo expects to start selling its generic sumatriptan tablets in January 2009.

Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.

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