FDA Extends Prasugrel Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug’s application was accepted in February 2008 and its deadline for action was this week. The new action date is September 26, 2008. The proposed indication for Effient is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). The three-mon...

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