Joint session of the

Nonprescription Drugs Advisory Committee

and the

Advisory Committee for

Reproductive Health Drugs

 

December 16, 2003

 

NDA 21-045 - proposing over-the-counter (OTC) use of Plan B (levonorgestrel)

 

 

Index

 

Tab 1 Meeting Agenda, including Discussion Points to Consider

 

Tab 2 Review of the Plan B OTC Label Comprehension Study

 

      Review from the Division of Surveillance, Research and Communication Support

      Medical Officer Review

 

Tab 3 Review of the Actual Use Study

      Executive Summary

      Summary of Results of Actual Use of Low Comprehension Concepts from the Label Comprehension Study

      Plan B OTC Actual Use Study

 

Tab 4 Review of Behavior Study Literature

 

      Sexual and Contraceptive Behavior Studies on Plan B

 

Tab 5 Plan B Safety Review

 

      Medical Officer Review

      Office of Drug Safety, Division of Drug Risk Evaluation Review

      Review of Teratogenic Risk of Hormonal Products for Contraception

 

Tab 6 Draft Label

 

Tab 7 (to be distributed the first week of December)

Overview of existing and potential non-prescription distribution mechanisms