Ablavar 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 History and FDA Approval Process for Ablavar
|Dec 22, 2008|| 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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