Feridex labeling changes "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Advanced Magnetic's sNDA for Feridex I.V. provides "insufficient" data, FDA says in an Aug. 27 "not approvable" letter. The firm was seeking rapid infusion dosing and labeling claims regarding the characterization of liver lesions as benign or malignant. The contrast agent was approved in 1996 for use with MRI to aid in the detection and evaluation of liver lesions
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