Combidex Gets Second "Approvable" Letter: Additional Data Needed
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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
You may also be interested in...
Advanced Magnetics To Weigh European Data For Combidex Resubmission
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.
Advanced Magnetics Touts Ferumoxytol’s Fast Dosing, Potential Outpatient Use
Advanced Magnetics is touting faster administration with its lead compound ferumoxytol compared to conventional intravenous iron replacement therapies as well as potential utility in outpatient settings
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