September 18-19,2000


Accutane NF (isotretinoin) Capsules NDA 21-177

Hoffmann-La Roche Inc.

Cover Letter

FDA Briefing Information doc pdf

FDA Bibliography doc pdf

Appendix I doc pdf

Chemical Structure

Appendix II Overview of Accutane and Pregnancy Exposure

Accutane (isotretinoin) Capsules NDA 18-662


The statements contained in this document 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.

Hoffmann-La Roche Inc.

Cover Letter

Table of Contents

Executive Summary

Benefits of Accutane

Use & Acne Pharmacoepidemiology

Pregnancy Prevention Program

Hormonal Contraceptive

Psychiatric Conditions


Appendix 1 Accutane Package Insert (June 2000)

Appendix 2 IMS-Roche NDC Patient Methodology Comparison

Appendix 3 Factors Contributing to the Increased Use of Accutane

Appendix 4 Stern Analysis of Medication and Medical Service Utilization for Acne

Appendix 5 Methodology for UHC Pregnancy Study

Appendix 6 Warnings in 1982 Package Insert

Appendix 7 Review of Pregnancy Reports

Appendix 8 List of Potentially Teratogenic Drugs Commonly Used in Dermatology

Appendix 9 Contraceptive Certificate Programs

Appendix 10 Interim Study Report for Protocol NR15888

Appendix 11 Interim Study Report for Protocol NR15792

Appendix 12 Analyses Used in Psychological Autopsy

Appendix 13 Review of All Spontaneous Reports of Psychiatric Conditions

Survey of Accutane Use in Women

FDA Background Information doc pdf