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Thursday, March 10, 2011

Gadavist to be released by Bayer....very soon

On Thursday, February 10, 2011, a U.S. federal trademark registration was filed for GADAVIST. This trademark is owned by Bayer Schering Pharma AG, Berlin 13353. The USPTO has given the GADAVIST trademark serial number of85239263


. The current federal status of this trademark filing is NEW APPLICATION - RECORD INITIALIZED NOT ASSIGNED TO EXAMINER.An advisory committee of the U.S. Food and Drug Administration (FDA) today voted unanimously to recommend approval for Bayer HealthCare Pharmaceuticals' Gadovist 1.0 (gadobutrol), a gadolinium-based contrast agent for contrast-enhanced MRI of the central nervous system.

The panel also voted 15-1 to allow Gadovist to be labeled without a contraindication for nephrogenic systemic fibrosis (NSF) in the population at risk for the debilitating disease. However, they advised that Gadovist should carry the same black box warning label required of other gadolinium-based contrast agents (GBCAs) sold in the U.S.
On the recommendation for approval, James Tatum, MD, a nuclear medicine physician with the Veterans Administration, echoed the consensus of his panel colleagues. "I feel that safety data and the efficacy data is at least as good as the approved agents and possibly better," he commented after the vote.
Clinical data indicate that Gadovist can be classified as one of the lower-risk gadolinium-based contrast agents in terms of NSF risk, according to panel member Donna Roberts, MD, a neuroradiologist at the Medical University of South Carolina in Charleston and at St. Jude Children's Research Hospital in Memphis, TN.









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