Table of Contents
Tab 1 Cover Letter - Dr.
George Mills, Division Director
[PDF]
Tab 2 Executive Summary
[PDF]
Tab 3 Draft Discussion
Points
[PDF]
Tab 4 Introduction
[PDF]
4.1 Product Information
4.2 Indication and Current Available Diagnostic Modalities
4.3 Overview of Clinical Development Program
4.4 Review of Regulatory History
Tab 5 Efficacy Review
[PDF]
5.1 Overview of Phase 3 clinical program
5.2 Study Design
5.2.1 A prospectively defined
analysis from a single US Phase 3 trial
5.2.2 A prospectively defined pooled
analysis from three European trials
5.3 Primary Efficacy Results
5.3.1 Description of analytical
population
5.3.2 Primary efficacy results
5.3 Additional Analyses
5.4 Discussion of a study published in New England
Medicine Journal of
5.5 Efficacy Summary
Tab 6 Safety Review
[PDF]
6.1 General adverse event
profile
6.2 Adverse event of special
interest –
an anaphylactic/
anaphylactoid reaction
6.3
Anaphylactic/anaphylactoid reactions of
other relevant drug products
6.4 Safety Summary
Tab 7 Appendices
7.1 Proposed
Combidex product labeling
[PDF]
7.2 Torabi M
et al: Current Concepts in Lymph Node Imaging. ) Nucl Med 2004; 45:1509-1518
7.3 Harisinghani
M et al: Noninvasive Detection of Clinically Occult Lymph-Node Metastases in
Prostate Cancer. N En g Med 2003;348:2491-9
7.4 Summary of
Combidex Use and Imaging Procedures
[PDF]
7.5 FDA Guidance for Industry -
Developing Medical Imaging Drug and
Biological Products Part 3:
Design, analysis, and Interpretation of Clinical
Studies
[PDF]
7.6 Reading Guideline used in
European Trials
[PDF]
7.7 Correlation between Guerbert
Guideline and AMI Guideline
(Combidex Imaging Guideline)
[PDF]
7.8 Case Report Form for Patient
#224 under Protocol 38804-8A
[PDF]
7.9 Feridex IV product labeling
cases of anaphylaxis associated with
marketed iron-based products from
post-marketing surveillance in the
[PDF]
7.10 FDA's Office of Drug Safety:
Summary analysis of fatal
[PDF]
7.11 Hamstra R et al: Intravenous iron
Dextran in Clinical Medicine. )AMA 1980; 243:1726-173 Fishbane S et al: The
Safety of Intravenous Iron Dextran i n Hemodialysis
Patients. Am J Kidney Dis 1996: 28:529-34