Gastrointestinal Drugs Advisory Committee
June 27, 2000
NDA 21-107, Lotronex (alosetron) Glaxo Wellcome
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document
FDA Presentation
Tab 1 Overview and Risk Management Issues for Lotronex (Alosetron HCl) Tablets
Tab 2 Summary Gastrointestinal of Serious Adverse Events
Tab 4 Risk Interventions and Their Evaluation
Appendix 2 LotronexÔ (alosetron HCl) Tablets: review of efficacy and safety
FDA review #1: overview of efficacy and safety (November 17, 1999)
FDA review #2: review of safety (January 27, 2000)
Appendix 3: Lotronex (alosetron HCl) Tablets labeling
Appendix 4: Regulations, guidances, and examples applicable to risk management