Advanced Magnetics To Weigh European Data For Combidex Resubmission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Advanced Magnetics will consider using clinical trial data generated by its European marketing/development partner Guerbet to respond to a March 2005 FDA "approvable" letter for its molecular imaging agent Combidex (ferumoxtran-10) for use with MRI, the company said.
You may also be interested in...
Combidex Gets Second "Approvable" Letter: Additional Data Needed
Advanced Magnetics Combidex MRI imaging agent data request from FDA clouds timeline to marketing clearance. Agency "approvable" letter echoes advisory committee’s desire for more efficacy data
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product