Pulmonary/Allergy Drugs Advisory Committee Meeting

Jan 17, 2002

Holiday Inn Gaithersburg

Flovent Diskus (NDA# 20-833/S-004) and Advair Diskus (NDA# 21-077/S-003) as long-term maintenance therapy in patients with Chronic Obstructive Pulmonary Disease (COPD).

 

8:00 Welcome Mark S. Dykewicz, M.D.

Conflict of Interest Statement Kimberly Topper

8:15 Welcome and Topic Introduction Robert Meyer, M.D.

8:30 GlaxoSmithKline Presentations

Introduction Dr. David Wheadon

Scientific & Clinical Rationale Dr. Malcolm Johnson

Clinician's Perspective Dr. James Donohue

Clinical Efficacy & Safety Dr. Tushar Shah

Conclusions and Q&A Dr. David Wheadon

10:15 Break

10:30 FDA Presentations

Flovent Diskus for COPD Dr. Charles Lee

Advair Diskus for COPD Dr. Lydia Gilbert-McClain

Summary and Issues for PADAC Dr. Mary Purucker

12:00 Lunch

1:00 Open Public Hearing

Sol Epstein, MD, FRCP, FACP

2:00 Discussion

3:00 Break

3:15 Questions

5:00 Adjourn