DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE
September 18-19,2000
BRIEFING INFORMATION
Accutane NF (isotretinoin) Capsules NDA 21-177
Hoffmann-La Roche Inc.
FDA Briefing Information doc pdf
Appendix II Overview of Accutane and Pregnancy Exposure
Accutane (isotretinoin) Capsules NDA 18-662
DisclaimerThe 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.
Use & Acne Pharmacoepidemiology
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