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