Food and Drug Administration

Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs

December 16, 2003

Briefing Information

Disclaimer

The statements contained in this document(s) 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.

Briefing Document - Plan B® (Levonorgestrel) for Emergency Contraception Rx-to-OTC Switch, Women's Capital Corp. (HTM) (PDF) (Word)

Bibliography, Women's Capital Corp. (HTM) (PDF) (Word)

Table of Contents, FDA (HTM) (PDF) (Word)

Tab 1 Plan B Points, FDA (HTM) (PDF) (Word)

Tab 2-1 DSRCS Review, FDA (HTM) (PDF) (Word)

Tab 2-2 Plan B OTC Label Comprehension Study, FDA (HTM) (PDF) (Word)

Tab 3-1 Tab 3-2 Executive Summary of Actual Use Study, FDA (HTM) (PDF) (Word)

Tab 3-3 Plan B OTC Actual Use Study, FDA (HTM) (PDF) (Word)

Tab 4-1 Sexual and Contraceptive Behavior Studies on Plan B, FDA (HTM) (PDF) (Word)

Bibliography, FDA (HTM) (PDF) (Word)

Plan B® Safety Review, FDA (HTM) (PDF) (Word)

Tab 5-1 Medical Officer Safety Review, FDA (HTM) (PDF) (Word)

Tab 5-2 ODS Postmarketing Safety Review, FDA (PDF)

Tab 5-3 Teratogenic Risk of Hormonal Products for Contraception: A Review of the Literature, FDA (HTM) (PDF) (Word)

Tab 6 Plan B Labeling, FDA (PDF)

Tab 7 Overview of Existing State Distribution Mechanisms and Barr's Proposed Educational Program and Distribution for Plan B, FDA (HTM) (PDF) (Word)

Errata, FDA (HTM) (PDF) (Word)