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

Table of Contents

Tab 1 Overview and Risk Management Issues for Lotronex (Alosetron HCl) Tablets

Tab 2 Summary Gastrointestinal of Serious Adverse Events

Tab 3 Risk Management Options

Tab 4 Risk Interventions and Their Evaluation

Appendix 2 Lotronex (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

  1. Labeling

  2. Communications to healthcare providers and consumers

  3. Advertising

  4. Restricted distribution

  5. Cessation of marketing