Skip to main content

Ablavar

Generic name: gadofosveset trisodium
Treatment for: Diagnosis and Investigation

FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters

CAMBRIDGE, Mass., July 28, 2006 - EPIX Pharmaceuticals, Inc., a developer of innovative pharmaceuticals for magnetic resonance imaging (MRI) which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that the U.S. Food and Drug Administration (FDA) has advised EPIX that it is extending its review of the formal appeal submitted by the Company on June 30th, 2006. In the appeal, EPIX asked the FDA to approve the Company's novel blood-pool imaging agent Vasovist and to use an Advisory Committee as part of the appeal process. The FDA indicated that it expects to respond to the appeal in September 2006.

"We appreciate the FDA's willingness to take this additional time to review our appeal of the Vasovist approvable letters," said Andrew Uprichard, M.D., EPIX's President and Chief Operating Officer. "We look forward to hearing the FDA's response to our appeal in September."

Related articles

Ablavar (gadofosveset trisodium) FDA Approval History

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.