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
|Dec 22, 2008||Approval EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)|
|Jul 1, 2008||EPIX Pharmaceuticals Announces Resubmission of New Drug Application
|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|
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