FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

AGENDA

March 4, 2003

Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD

NDA 21-158, Factive^® (gemifloxacin) Tablets, Parexel International, U.S. Agent for LG LifeSciences, Ltd., proposed for the treatment of community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis

8:00 a.m. Call to Order James E. Leggett, Jr., M.D.

Acting Chair, AIDAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AIDAC

8:10 a.m. Opening Remarks Renata Albrecht, M.D. Director

Division of Special Pathogen and

Immunologic Drug Products, FDA

8:20 a.m. Adverse Cutaneous Drug Reactions Michael Bigby, M.D.

Assistant Professor of Dermatology

Harvard Medical School

8:50 a.m. Antimicrobial Resistance in John H. Powers, M.D.

Streptococcus pneumoniae Lead Medical Officer for

Antimicrobial Drug Development

Office of Drug Evaluation IV, FDA

9:20 a.m. Break

9:30 a.m. Sponsor Presentation Parexel International,

US Agent for LG Life Sciences Ltd.

Introduction Gary Patou, M.D.

President, GeneSoft Pharmaceuticals

Unmet Medical Need Donald E. Low, M.D.

Professor, Microbiology and Medicine

University of Toronto

Efficacy Lionel A. Mandell, M.D.

Professor of Medicine

Chief of Infectious Diseases

McMaster University

Safety Gary Patou, M.D.

Neil H. Shear, M.D.

Professor and Chief of Dermatology

University of Toronto

Benefit/Risk and Risk Management Gary Patou, M.D.

11:00 a.m. Questions and Answers

11:10 a.m. Break

11:20 a.m. FDA Presentation

Microbiology Peter Dionne

Microbiologist

Division of Special Pathogen and

Immunologic Drug Products, FDA

Community-Acquired Pneumonia Regina Alivisatos, MD.

Medical Officer

Division of Special Pathogen and

Immunologic Drug Products, FDA

Acute Bacterial Exacerbation of Chronic Bronchitis Eileen Navarro, M.D.

Medical Officer

Division of Special Pathogen and

Immunologic Drug Products, FDA

Safety Maureen Tierney, M.D., M.Sc.

Medical Officer

Division of Special Pathogen and Immunologic Drug Products, FDA

12:30 p.m. Questions and Answers

12:40 p.m. Lunch

1:40 p.m. Open Public Hearing

2:00 p.m. Charge to the Committee Mark Goldberger, M.D., M.P.H.

Director

Office of Drug Evaluation IV, FDA

2:10 p.m. Committee Discussion

3:20 p.m. Break

3:30 p.m. Continued Discussion and Vote

5:00 p.m. Adjourn