DERMATOLOGIC AND OPTHALMIC DRUGS ADVISORY COMMITTEE
June 29, 2000
Briefing Information
FDA background Materials
NDA 20-010 Contents
Tab 1 Antifungal/Corticosteroid Combination Topical Products:
Overview and Questions
Tab 3 Executive Summary, NDA 20-010 LOTRISONE (betamethasone dipropionate and clotrimazole) LOTION
Tab 4 Questions to the Dermatologic and Ophthalmic Drugs Advisory Committee
Tab 5 Patient Package Labeling
Tab 6 Executive Summary: Lotrisone Adverse Events
Tab 7 Executive Summary: Lotrisone Labeling Options
Appendix I Adequate and Well-Controlled Studies (21CFR 314.126)
Attachment 1 Copy of Protocol of Studies for NDA 20-996
Attachment 2
Samples of Case Report Forms in NDA 20-996