Epix files Vasovist appeal with FDA

Epix Pharmaceuticals of Cambridge, MA, has submitted a formal appeal to the U.S. Food and Drug Administration to approve the company's blood-pool imaging agent Vasovist.

Vasovist is an injectable, intravascular contrast agent designed to provide visual imaging of the vascular system through MR angiography. Epix is targeting an initial indication for imaging of noncoronary vascular disease.

In October 2005, the European Medicines Agency granted marketing approval of Vasovist for all 25-member states of the European Union. Epix's Vasovist partner, Schering of Berlin, began marketing the imaging agent in Europe in the second quarter this year.

By AuntMinnie.com staff writers
July 4, 2006

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