Vasovist
gadofosveset trisodium
Treatment for DiagnosticFDA 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
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
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EPIX Submits Response to FDA Approvable Letter - May 23, 2005
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