Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee

September 6, 2002

Briefing Information

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Spiriva (tiotropium bromide) Inhalation Powder, NDA 21-395, Boehringer Ingelheim Pharmaceuticals, Inc.  pdf

Table of Contents  doc  htm  pdf

Memo dated August 6, 2002, from Division Director to Committee Members  doc  htm  pdf

Disclaimer Statement  doc  htm  pdf

Clinical Briefing Document  Spiriva (tiotropium bromide) Inhalation Powder for COPD  doc  htm   pdf

Clinical Briefing Part 1  pdf

Clinical Briefing Part 1-A  pdf

Clinical Briefing Part 2  pdf

Clinical Pharmacology and Biopharmaceutics Briefing Document  doc  htm  pdf

Bibliography  doc  htm  pdf