Food and Drug Administration
Center for Drug Evaluation
and Research
Pulmonary-Allergy Drugs Advisory
Committee
Holiday Inn,
Agenda
NDA 21-573, ArifloTM (cilomilast) Tablets 15mg, by GlaxoSmithKline,
for use in Chronic Obstructive Pulmonary Disease (COPD)
Conflict of Interest
Statement Kimberly
L. Topper, M.S.
Introduction David
Wheadon, M.D.
Rationale for the Use of
Ariflo in COPD Katharine
Knobil, M.D.
Efficacy Data from Ariflo
Clinical Program Katharine Knobil,
M.D.
Safety of Ariflo Kathy
Rickard, M.D.
Assessment of Outcome in
COPD Frank Sciurba,
M.D.
Conclusion David
Wheadon, M.D.
Introduction Raymond
Anthracite, M.D.
Preclinical
Pharmacology-Toxicology Virgil
Whitehurst, Ph.D.
Dose-Finding Sandra
Suarez-Sharp, Ph.D.
Statistics James
Gebert, Ph.D.
Efficacy & Safety Raymond
Anthracite, M.D.