Food and Drug Administration

Gastrointestinal Drugs Advisory Committee

July 14, 2004


Outline, Dr. John Cutt, PhD, Novartis (HTM) (PPT)

Zelnorm® (tegaserod maleate) - Introduction (HTM) (PPT)

Chronic Constipation: An Unresoved Problem for Many Patients, Dr. Chalene Prather, MD (HTM) (PPT)

Zelnorm® (tegaserod maleate) - Efficacy and Safety in Chronic Constipation, Dr. Eslie Dennis, MD (HTM) (PPT)

Zelnorm® (tegaserod maleate) - Safety Overview, Dr. Bo Joelsson, MD, PhD, Novartis (HTM) (PPT)

Zelnorm® (tegaserod maleate) - Benefit/Risk, Philip Schoenfeld, MD, MSEd, MSc (Epi) (HTM) (PPT)

Efficacy of Zelnorm® for Chronic Constipation, Dr. Robert Prizont, MD, FDA (HTM) (PPT)

Zelnorm® (tegaserod), Dr. Gary Della'Zanna, DO, MSc, FACOS; Ann Mackey, RPh, M; Dr. Allen Brinker, MD, MS (HTM) (PPT)

Discussion Question (HTM) (PPT)

Open Public Hearing

Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome Association, Jeffrey Roberts, BSc (HTM) (PPT)

Written Statement Presented by Jeffrey Roberts, BSc (HTM) (PDF) (Word)