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Ablavar Approval History

  • FDA approved: Yes (First approved December 22nd, 2008)
  • Brand name: Ablavar
  • Generic name: gadofosveset trisodium
  • Previous name: Vasovist
  • Company: EPIX Pharmaceuticals, Inc.
  • Treatment for: Diagnosis and Investigation

Ablavar - formerly Vasovist - (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

DateArticle
Dec 22, 2008Approval EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)
Jul  1, 2008EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist
Apr  2, 2007EPIX Provides Update Regarding Status of Vasovist Appeal
Feb 28, 2007Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research
Dec 14, 2006Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist
Aug 28, 2006Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters
Jul 28, 2006FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters
Jun 30, 2006EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters
Nov 23, 2005FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist
May 23, 2005EPIX Submits Response to FDA Approvable Letter
Jan 14, 2005FDA has completed its review of the NDA for MS-325

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