Regulatory signs look good for AMI agent
Advanced Magnetics passed an important milestone earlier thismonth when the Food and Drug Administration issued a letter statingthat the new drug application for the company's Feridex MRI contrastagent is approvable. Advanced Magnetics, of Cambridge, MA,
Advanced Magnetics passed an important milestone earlier thismonth when the Food and Drug Administration issued a letter statingthat the new drug application for the company's Feridex MRI contrastagent is approvable. Advanced Magnetics, of Cambridge, MA, saidthat it is working with the FDA on final labeling for the agentas well as to resolve several questions relating to the NDA, whichwas filed in February 1994.
Feridex is an intravenous contrast agent designed to enhanceprimary and metastatic tumors in the liver on MRI scans. AdvancedMagnetics has licensed the agent to Berlex Laboratories in theU.S. and Canada (SCAN 2/15/95). Feridex is sold in Europe by Guerbetunder the trade name Endorem.