Food and Drug Administration

Gastrointestinal drugs ADvisory Committee

July 14, 2004

Briefing Information

Zelnorm™ for Treatment of Chronic Constipation

Briefing Document, Novartis Pharmaceuticals Corp. (PDF)

Bibliography, Novartis Pharmaceuticals Corp. (PDF)

Appendix A. Novartis Survey of Consumers Suffering From Constipation - Summary of Findings (PDF)

Appendix B. Tegaserod: Update on Clinical Efficacy Profile (PDF)

Briefing Document, FDA (HTM) (PDF) (Word)

Addendum. Revision to the FDA Briefing Document (HTM) (PDF) (Word)

Appendix 1. Important Drug Warning, FDA (PDF)

Appendix 2. Zelnorm® (tegaserod maleate) Labeling, FDA (PDF)