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