Shire Pulls US Drug Application, Blames FDA Delay

Law360, New York (March 15, 2012, 1:49 PM EDT) -- Irish pharmaceutical company Shire PLC said Wednesday that it has pulled its U.S. application for Replagal, which treats a rare and potentially life-threatening genetic disorder, because regulators would take too long to approve the drug.

The Dublin-based company has been in an ongoing dialogue with the U.S. Food and Drug Administration ever since Sanofi SA subsidiary Genzyme Corp. ran short of Fabrazyme, the only U.S.-approved treatment for Fabry disease. Genzyme announced the end of the shortage early this month, when it began shipping the product from...
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