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Combidex Approval Status

FDA Approved: No
Brand name: Combidex
Generic name: ferumoxtran-10
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Body Imaging

Combidex (ferumoxtran-10) is a investigational functional molecular imaging agent intended for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from non-cancerous lymph nodes.

In March 2005, Advanced Magnetics, Inc. announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) requesting additional data to demonstrate the efficacy of Combidex (ferumoxtran-10).

Development Status and FDA Approval Process for Combidex

DateArticle
Mar 24, 2005Advanced Magnetics, Inc. Receives Approvable Letter From FDA For Combidex
Mar  3, 2005Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex
Feb  1, 2005Advanced Magnetics' Combidex to be Reviewed by FDA Oncologic Drugs Advisory Committee

Further information

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