Endocrinologic and Metabolic Drugs Advisory Committee

September 8, 2005

Food and Drug Administration Briefing Information

Table of Contents

1. Background and Summary

 

2. Draft Questions for the Committee

 

3. Clinical Pharmacology and Biopharmaceutics

 

4. Pharmacology/Toxicology

 

5. Clinical Efficacy Statistics

 

6. Pulmonary Safety Statistics

 

7. Clinical Efficacy Review

                   Part 1         (Pages 001-099)

                   Part 2         (Pages 100-199)

                   Part 3         (Pages 200-295)

 

8. Clinical Pulmonary Safety

                   Part 1         (Pages 001-099)

                   Part 2         (Pages 100-149)

 

9. Errata Sheet