Food and Drug Administration
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)