Ablavar
Generic name: gadofosveset trisodium
Treatment for: Diagnosis and Investigation
EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters
CAMBRIDGE, Mass., June 30, 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 it has submitted a formal appeal to the U.S. Food and Drug Administration (FDA) asking the FDA to approve the Company's novel blood-pool imaging agent Vasovist. The Company submitted the appeal to the Office of New Drugs of the FDA and has asked that an Advisory Committee be utilized as part of the appeal process. The Company expects that the Office of New Drugs will respond to the Company's submission within approximately 30 days, although any decision could be delayed if the Office of New Drugs grants the Company's request for an Advisory Committee.
"The submission of this appeal is the next step in a long process and represents a substantial undertaking for our company and underscores our confidence in the clinical profile and benefits of Vasovist," commented Dr. Andrew Uprichard, EPIX President and COO. "We are hopeful that we will have the opportunity to present the data from our four completed Phase III trials, as well as other data collected on Vasovist, to an Advisory Committee as part of the appeal process, and are continuing preparations accordingly."
Vasovist, EPIX's lead product candidate, is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. EPIX's initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease. In October 2005, the European Medicines Agency granted marketing approval of Vasovist for all 25 member states of the E.U. Schering AG, Germany, EPIX's partner for Vasovist, began marketing Vasovist in Europe in the second quarter of 2006.
Posted: June 2006
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- 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
- FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters - July 28, 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
Ablavar (gadofosveset trisodium) FDA Approval History
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