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Resubmission of NDA for Vasovist
EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist
LEXINGTON, Mass.--(BUSINESS WIRE)--Jul 1, 2008 - EPIX Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced today that the New Drug Application (NDA) for its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium) was resubmitted to the U.S. Food and Drug Administration (FDA) on June 30, 2008.
If approved, Vasovist will be the first contrast agent approved for marketing in the United States for use with MRA, a non-invasive modality for imaging blood vessels. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents.
"We look forward to continuing to work with the FDA to bring Vasovist to market in the United States," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "Throughout the appeal process for Vasovist, we worked closely with the FDA and the resubmission is a culmination of the work done by our team at EPIX. We remain hopeful that we will achieve approval for Vasovist by the end of 2008 and are focused on executing our strategy to monetize our interest in this valuable asset."
Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, all Nordic countries, the United Kingdom and Switzerland.
Posted: July 2008
- EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium) - December 22, 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
- FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters - July 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