Table of Contents

 

 

 

Tab 1 - Background and summary of risk management plan

 

 

 

Tab 2 - Summary of outcomes under the risk management plan

 

 

 

Tab 3 - FDA summary of adverse events

 

 

 

Tab 4 - The FDA approval letter dated June 7, 2002 that provides for the risk

              management plan for Lotronex and the approved labeling

 

 

 

Tab 5 - Office of Drug Safety Post-marketing Safety Review of April 1, 2004