The U.S. Food and Drug Administration (FDA) has extended its review of Epix Pharmaceuticals' formal appeal for approval of the Cambridge, MA-based company's Vasovist blood-pool imaging agent.
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 a letter sent to Epix in November 2005, the FDA indicated that at least one additional clinical trial, and a reread of images obtained in certain of the previously completed phase III trials, would be necessary before it could approve Vasovist.
The FDA expects to respond to the company's appeal in September.
By AuntMinnie.com staff writers
July 28, 2006
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Epix files Vasovist appeal with FDA, July 4, 2006
Astrue resigns from Epix, May 8, 2006
Epix to buy Predix Pharmaceuticals, April 3, 2006
Epix adds VPs, February 23, 2006
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