DERMATOLOGIC AND OPTHALMIC DRUGS ADVISORY COMMITTEE

June 29, 2000

Briefing Information

FDA background Materials

Cover Letter

NDA 20-010 Contents

Tab 1 Antifungal/Corticosteroid Combination Topical Products: Overview and Questions

Tab 2 Questions for DODAC

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

NDA 20-996 Summary of Clinical Information on NDA 20-996 for the Dermatologic and Ophthalmologic Drugs Advisory Committee

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