Advanced Magnetics Feridex I.V. sNDA
Executive Summary
FDA tells Advanced Magnetics sNDA for rapid infusion dosing regimen of Feridex I.V. is "not approvable" Aug. 17. Feridex I.V. is already marketed as a contrast agent to detect liver lesions. Advanced Magnetics is seeking approval for rapid infusion and for claims relating to lesion characterizations as benign or metastatic