Epix to resubmit NDA for Vasovist

By AuntMinnie.com staff writers

April 24, 2008 -- MRI contrast developer Epix Pharmaceuticals of Lexington, MA, is reporting its results from a blinded, independent reread of images of its blood-pool MRI contrast agent, Vasovist (gadofosveset trisodium).

In the reread of images obtained from previous phase III studies, the company said that it has met all prespecified points agreed to with the U.S. Food and Drug Administration (FDA).

Epix plans to resubmit a new drug application (NDA) to the FDA for Vasovist in mid-2008. Vasovist currently is approved for marketing in 33 countries.

Epix reaches agreement with FDA over Vasovist, February 1, 2008

Epix to raise $16.3 million, November 12, 2007

Epix receives FDA response, June 19, 2007

Epix posts big Q1 loss, May 9, 2007

Epix chairman to retire, May 2, 2007

Copyright © 2008 AuntMinnie.com

 

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