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FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters
CAMBRIDGE, Mass., July 28, 2006 - EPIX Pharmaceuticals, Inc., a developer of innovative pharmaceuticals for magnetic resonance imaging (MRI) which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that the U.S. Food and Drug Administration (FDA) has advised EPIX that it is extending its review of the formal appeal submitted by the Company on June 30th, 2006. In the appeal, EPIX asked the FDA to approve the Company's novel blood-pool imaging agent Vasovist and to use an Advisory Committee as part of the appeal process. The FDA indicated that it expects to respond to the appeal in September 2006.
"We appreciate the FDA's willingness to take this additional time to review our appeal of the Vasovist approvable letters," said Andrew Uprichard, M.D., EPIX's President and Chief Operating Officer. "We look forward to hearing the FDA's response to our appeal in September."
Posted: July 2006
- EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium) - December 22, 2008
- EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist - July 1, 2008
- EPIX Provides Update Regarding Status of Vasovist Appeal - April 2, 2007
- Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research - February 28, 2007
- Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist - December 14, 2006
- Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters - August 28, 2006
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters - June 30, 2006
- FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist - November 23, 2005
- EPIX Submits Response to FDA Approvable Letter - May 23, 2005
- FDA has completed its review of the NDA for MS-325 - January 14, 2005