Ablavar
Generic name: gadofosveset trisodium
Treatment for: Diagnosis and Investigation
FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist
BERLIN, Germany, November 23, 2005 -- Schering AG, Germany announced today that its development partner, EPIX Pharmaceuticals, Inc. , received an approvable letter from the U.S. Food and Drug Administration (FDA) for Vasovist (gadofosveset trisodium).
In the letter, the FDA indicated that at least one additional clinical trial, and a re-read of images obtained in previously completed Phase III trials, will be necessary before the agency could approve Vasovist. No safety or manufacturing issues were raised in the approvable letter.
In October 2005, Vasovist was approved in all EU member states, making it the first in a new class of blood-pool contrast agents for magnetic resonance angiography (MRA) to diagnose vascular disease. Under the European labeling, Vasovist is indicated for visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis or aneurysms.
Vasovist was co-developed under a strategic partnership with EPIX Pharmaceuticals. Schering AG has the global marketing rights for the product and will continue to support EPIX in their efforts to address the requests of the FDA.
Source: Schering AG
Posted: November 2005
Related articles
- EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium) - December 22, 2008
- 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
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters - June 30, 2006
- 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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