Food and Drug Administration

Center for Drug Evaluation and Research

Endocrinologic and Metabolic Drugs Advisory Committee

Holiday Inn Bethesda, 8120 Wisconsin Avenue, Bethesda, MD

Agenda

July 27, 2001

NDA 21-318, FortéoTM (teriparatide injection, rDNA origin) Eli Lilly and Company

 

8:00 Call to Order and Introductions: Mark E. Molitch, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

8:15 Welcome and Introduction: David G. Orloff, M.D., Director

Division of Metabolic and Endocrine Drug Products

8:30 Eli Lilly and Company Presentation

Introduction:    Jennifer L. Stotka, MD, Executive Director,

US Regulatory Affairs, Eli Lilly and Company

History, Mechanism of Action and Clinical Need:  Robert Lindsay, MD, PhD
Professor of Clinical Medicine, Columbia University
                                        Chief of Internal Medicine, Helen Hayes Hospital
Nonclinical Overview:  John L. Vahle, DVM, PhD, Senior Research Pathologist,
                                        Toxicology, Eli Lilly and Company
Clinical Efficacy:  Bruce H. Mitlak, MD, Medical Director, Fortéo Product Team
                                        Eli Lilly and Company
Clinical Safety:  Gregory A. Gaich, MD , Senior Research Clinical Physician,

Fortéo Product Team, Eli Lilly and Company
Summary and Conclusions:  Bruce H. Mitlak, MD
                                       

10:00 Break

10:15 FDA Presentation: Division of Metabolic and Endocrine Drug Products

Preclinical Studies: Gemma Kuijpers, Ph.D.

Efficacy: Bruce S. Schneider, M.D.

Safety: Bruce V. Stadel, M.D., M.P.H.

11:15 Open Public Hearing

11:45 Lunch

1:00 Charge to the Committee: David G. Orloff, M.D., Director

Division of Metabolic and Endocrine Drug Products

Discussion and Questions

Break

4:30 Summary and Review

5:00 Adjourn