Business Update

FDA accepts submission following Vasovist approvable letter

Published in Medical Letter on the CDC and FDA, August 7th, 2005

EPIX Pharmaceuticals, Inc., (EPIX) announced that the U.S. Food and Drug Administration (FDA) has accepted EPIX's submission of May 2005 as a complete response to the approvable letter received from the U.S. Food and Drug Administration in January, 2005, for Vasovist (MS-325).

The FDA indicated it would review EPIX's new drug application (NDA), including the May, 2005, submission, with a target date for an action letter in late November 2005. The FDA also encouraged EPIX to consider a reread of the images from the phase III trials to provide additional information about the usefulness of dynamic versus steady state images, and to schedule a meeting with the FDA to...

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Source: Medical Letter on the CDC and FDA (2005-08-07)

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