Endocrinologic and Metabolic Drugs Advisory Committee



September 8, 2005


The committee will discuss new drug application (NDA) 21-868,

 proposed trade name Exubera (insulin recombinant deoxyribonucleic acid (rDNA) origin powder for oral inhalation),

 1 milligram (mg) and 3 mg powder for inhalation, Pfizer, Inc., for the treatment of adult patients with diabetes mellitus


Pfizer Global Research and Development: Presentation


                Introduction                                                                          Neville Jackson, M.D.

Full Development Team Leader, EXUBERA

Pfizer Global Research and Development

                                                                                                [HTML] [PPT]


Overview of Clinical Program                                             Anne Cropp, Pharm.D.

Global Clinical Leader, EXUBERA

Pfizer Global Research and Development

                                                                                                [HTML] [PPT]


Medical Needs                                                                     William Cefalu, M.D.

Professor and Chief, Department of Nutrition and Chronic Diseases

Pennington Biomedical Research Center, LSU

                                                                                                [HTML] [PPT]


Benefit and Managing the Risk                                         Neville Jackson, M.D.

                                                                                                Pfizer Global Research and Development

                                                                                                [HTML] [PPT]


ClinPharm Backup Slides                                                    [HTML] [PPT]


Efficacy Backup Slides                                                        [HTML] [PPT]


Non-Clinical Backup Slides                                                [HTML] [PPT]


Pulmonary Safety Backup Slides                                       [HTML] [PPT]


Risk Management Backup Slides                                      [HTML] [PPT]


FDA Review Division Presentation:


                Clinical Efficacy and                                                            Karen M. Mahoney, M.D.

                Non-Pulmonary Safety Review                                          Medical Officer

                                                                                                                FDA/CDER Division Metabolic and Endocrine Drug Products

                                                                                                [HTML] [PPT]


                Statistical Review and Evaluation                                     Joy D. Mele, M.S.


                                                                                                                FDA/CDER Office of Pharmacoepidemiology and Statistical Science

                                                                                                [HTML] [PPT]


                Clinical Pharmacology and                                                 Sayed (Sam) Al Habet, R.Ph., Ph.D.

                Biopharmaceutics Review                                                  Senior Clinical Pharmacologist/Reviewer

                                                                                                                FDA/CDER Office of Clinical Pharmacology and Biopharmaceutics

                                                                                                [HTML] [PPT]


                Clinical Pulmonary Safety                                                   Sally Seymour, M.D.

                                                                                                                Medical Officer

                                                                                                                FDA/CDER Division of Pulmonary and Allergy Drug Products

                                                                                                [HTML] [PPT]



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Open Public Hearing

Statement Presented by Marc Sandberg, MD, et. al. [PDF]

Written Comment by Dr. Sills [PDF]

Statement Presented by Dr. Tomky [PDF]

Statement Presented by Dr. Valentine [PDF]