VasovistTreatment for Diagnostic
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
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- Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research - February 28, 2007
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