FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING

SUBCOMMITTEE FOR IMMUNOSUPPRESSANTS

January 24, 2002

Gaithersburg Holiday Inn

Two Montgomery Village Avenue

Gaithersburg, MD 20879

NDA 21-083 Rapamune® (sirolimus) Oral Solution – Maintenance Regimen

8:30 a.m. Call to Order and Opening Remarks Chair, AVAC,

Introduction of Committee

Executive Secretary, AVAC

8:40 a.m. FDA Introductory Remarks Renata Albrecht, M.D.

Acting Director

Division of Special Pathogen

and Immunologic Drug

Products, FDA

8:45 a.m. Sponsor Presentation

10:45 a.m. Break

11:00 a.m. FDA Presentation Rosemary Tiernan, M.D., M.P.H.

Medical Officer

Division of Special Pathogen

and Immunologic Drug

Products, FDA

(Tentative Speaker)

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

2:00 p.m. Charge to the Committee Renata Albrecht, M.D.

Acting Director

Division of Special Pathogen

and Immunologic Drug

Products, FDA

2:10 p.m. Committee Discussion and Vote

5:00 p.m. Adjourn