Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee

September 5, 2003

Briefing Information

Executive Summary, GlaxoSmithKline (PDF)

Introduction and Background, GlaxoSmithKline (PDF)

Nonclinical Findings, GlaxoSmithKline (PDF)

Clinical Pharmacology, GlaxoSmithKline (PDF)

Overview of Clinical Development Program, GlaxoSmithKline (PDF)

Study Design - Pivotal Studies, GlaxoSmithKline (PDF)

Pivotal Studies, GlaxoSmithKline (PDF)

Supporting Studies, GlaxoSmithKline (PDF)

Discussion of Benefit/Risk, GlaxoSmithKline (PDF)

Appropriate Use of Ariflo in the Management of COPD, GlaxoSmithKline (PDF)

References, GlaxoSmithKline (PDF)

Appendices, GlaxoSmithKline (PDF)

Table Contents, FDA (PDF)

Memorandum From Dr. Badrul Chowdhury, MD, FDA, Regarding Overview of the FDA Background Materials for NDA 21-573, Ariflo (cilomilast) Tablets, 15 mg, for the Maintenance of Lung Function (FEV1) in Patients Wtih Chronic Obstructive Pulmonary Disease (COPD) (PDF)

Disclaimer Statement, FDA (PDF)

Clinical Briefing with Table of Contents, FDA (PDF)

Summary of Clinical Pharmacology and Biopharmaceutics Findings, FDA (PDF)

Preclinical Considerations, FDA (PDF)

Ariflo® (cilomilast) Prescribing Information, FDA (PDF)

Theolair™ (theophyline tablets USP) Tablets, FDA (PDF)

Bibliography, (HTM) (PDF) (Word)