FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE MEETING

Slides

July 13, 2005

FDA Introductory Remarks Badrul Chowdhury, M.D.

Director, Division of Pulmonary-Allergy

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Guest Speaker Presentation

An Overview of Long-Acting Christine Sorkness, PharmD

Beta Agonists Professor of Pharmacy and Medicine

[HTML] [PPT] University of Wisconsin

Sponsor Presentation Glaxo Smith Kline

Opening Remarks C. Elaine Jones, Ph.D.

Vice President, Regulatory Affairs

Salmeterol Review Katharine Knobil, M.D.

Vice President,

Respiratory Clinical Development

Closing Remarks C. Elaine Jones, Ph.D.

Vice President, Regulatory Affairs

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Backup Slides

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Sponsor Presentation Novartis

Introduction Eric A. Floyd, M.S., M.B.A., Ph.D.

Vice President- Global Head RDI

[HTML] [PPT] Drug Regulatory Affairs Novartis

Efficacy and Safety of Gregory P. Geba, M.D., M.P.H.

Foradil® Vice President – U.S. Head RDI

Clinical Development and Medical

[HTML] [PPT] Affairs Novartis

Clinical Implications James F. Donohue, M.D.

Professor of Medicine

Chief of Pulmonary Division

University of North Carolina

[HTML] [PPT] Chapel Hill, North Carolina

FDA Presentation

Salmeterol Sally Seymour, M.D.

Medical Officer

[HTML] [PPT] Division of Pulmonary-Allergy Drugs

Formoterol J. Harry Gunkel, M.D.

Medical Officer,

[HTML] [PPT] Division of Pulmonary-Allergy Drugs

Question to the Committee

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Open Public Speakers

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