Food and Drug Administration

Advisory Committee for Reproductive Health Drugs

December 2, 2004

Slides

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.

Overview, Dr. Donna Griebel, MD, FDA (HTM) (PPT)

Presentation by Dr. Judith Hsai, MD FDA (HTM) (PPT)

Intrinsa™ (testosterone transdermal system), Dr. Joan Meyer, PhD (HTM) (PPT)

Androgenic AEs by Maximum Free T - Backup Information (HTM) (PPT)

Safety Issues in Chronic Androgen Therapy in Post-Menopausal Women: What We Know, What We Don't Know, Dr. Adrian Dobs, MD MHS, FDA (HTM) (PPT)

Efficacy of Testosterone Transdermal System (TTS) for Treatment of HSDD in Surgically Menopausal Women on Concomitant Estrogen, Dr. Daniel Davis, MD, MPH, FDA (HTM) (PPT)

Safety of Testosterone Transdermal System (TTS) for Treatment of HSDD in Surgically Menopausal Women on Concomitant Estrogen, Dr. Llisa Soule, MD, FDA (HTM) (PPT)

Most Frequently Reported Domestic SAEs With Estratest, Backup Information (HTM)

Open Public Hearing

Open Public Hearing Speakers (HTM) (PPT)

Wrong Turn on the Highway to Love, Dr. Leonore Tiefer, PhD, NYU School of Medicine (HTM) (PPT)

Potential Adverse Drug Reactions - Intrinsa, Dr. Karen Hicks, PhD, Dalkon Shield Info. Network (HTM) (PPT)

Androgen Therapy for Low Sexual Desire: A Concerned Physician's View, Dr. James Simon, MD, George Washington University (HTM) (PPT)

Comments, Dr. Raymond Rosen, PhD, Robert Wood Johnson Medical School, NJ (HTM) (PPT)