Food and Drug Administration

Advisory Committee for Reproductive Health Drugs

December 2, 2004

Briefing Information


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.

Intrinsa® (testosterone transdermal system) NDA No. 21-769 Briefing Document, Procter & Gamble Pharmaceuticals, Inc. (PDF)

Bibliography, Procter & Gamble Pharmaceuticals, Inc. (PDF)

FDA Review - NDA 21-769 Testosterone Transdermal System (proposed tradename, Intrinsa)

Overview (HTM) (PDF) (Word)

Medical Review (HTM) (PDF) (Word)

Appendix I - FDA Draft Guidaince for Industry Female Sexual Dysfunction Clinical Development of Drug Products for Treatment (PDF)

Appendix II - Applicant's Instruments to Assess Sexual Desire and Personal Distress (PDF)

Appendix III - Listing of Limits for Markedly Abnormal Laboratory Values (PDF)

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