Ablavar FDA Approval History
FDA Approved: Yes (Discontinued) (First approved December 22, 2008)
Brand name: Ablavar
Generic name: gadofosveset trisodium
Previous Name: Vasovist
Company: EPIX Pharmaceuticals, Inc.
Treatment for: Diagnosis and Investigation
Marketing Status: Discontinued
Ablavar (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
Development timeline for Ablavar
Date | Article |
---|
Dec 22, 2008 | Approval EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium) |
Jul 1, 2008 | EPIX Pharmaceuticals Announces Resubmission of New Drug Application
for Vasovist |
Apr 2, 2007 | EPIX Provides Update Regarding Status of Vasovist Appeal |
Feb 28, 2007 | Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research |
Dec 14, 2006 | Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist |
Aug 28, 2006 | Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters |
Jul 28, 2006 | FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters |
Jun 30, 2006 | EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters |
Nov 23, 2005 | FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist |
May 23, 2005 | EPIX Submits Response to FDA Approvable Letter |
Jan 14, 2005 | FDA has completed its review of the NDA for MS-325 |
Further information
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