Advanced Magnetics Combidex “Complete Response”
This article was originally published in The Pink Sheet Daily
Executive Summary
Advanced Magnetics' Combidex NDA has a user fee goal date of March 30, 2005
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Combidex Broad Indication Appropriateness To Be Topic For Advisory Committee
FDA questions whether Combidex can be used to detect metastatic lymph nodes in a broad range of cancer types. The agency will also ask the committee to discuss the product’s risk of anaphylactic/anaphylactoid reactions and recommend strategies to mitigate the risk.
Combidex Broad Indication Appropriateness To Be Topic For Advisory Committee
FDA questions whether Combidex can be used to detect metastatic lymph nodes in a broad range of cancer types. The agency will also ask the committee to discuss the product’s risk of anaphylactic/anaphylactoid reactions and recommend strategies to mitigate the risk.
Advanced Magnetics’ Combidex MRI Agent Will Get Committee Review
Imaging agent has a March 30, 2005 user fee date for use in differentiating metastatic and non-metastatic lymph nodes in at-risk cancer patients.