Advanced Magnetics seeks new Feridex labeling
Contrast media developer Advanced Magnetics announced in late December its submission to the FDA of a supplemental new drug application for Feridex I.V. The application seeks an expansion of indications to include differentiation of liver lesions as
Contrast media developer Advanced Magnetics announced in late December its submission to the FDA of a supplemental new drug application for Feridex I.V. The application seeks an expansion of indications to include differentiation of liver lesions as benign or metastatic. The company also hopes to change the dosing regimen to allow more rapid infusion. Expanding the labeling for Feridex I.V. could make the MRI contrast medium more competitive, according to the company. The agent, which was originally approved by the FDA on Aug. 30, 1996, is being marketed in the U.S. by Berlex Laboratories, a subsidiary of Schering of Germany.