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