Table of Contents

Tab 1 Cover Letter - Dr. George Mills, Division Director

Tab 2 Executive Summary

Tab 3 Draft Discussion Points

Tab 4 Introduction
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

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

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


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



7.5 FDA Guidance for Industry - Developing Medical Imaging Drug and

Biological Products Part 3: Design, analysis, and Interpretation of Clinical




7.6 Reading Guideline used in European Trials



7.7 Correlation between Guerbert Guideline and AMI Guideline

(Combidex Imaging Guideline)



7.8 Case Report Form for Patient #224 under Protocol 38804-8A



7.9 Feridex IV product labeling cases of anaphylaxis associated with

marketed iron-based products from post-marketing surveillance in the US



7.10 FDA's Office of Drug Safety: Summary analysis of fatal



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


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