Joint Meeting of the


October 20, 2000

Briefing Information

NDA 21-229 Omeprazole Magnesium Tablets

Procter & Gamble Company & ASTRA Zeneca LP Briefing Documents


The statements contained in this document 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.

Table of Contents

1 - Executive Summary

2 - Characterization of Heartburn Consumer

3 - Pathophysiology and Pharmacology

4 - Program Overview

5 - Efficacy Summary

6 - Consumer Research Studies

7 - Summary of Safety

8 - Special Safety Considerations

9 - Long-Term potential for Gastro-Intestinal Cellular Alterations

10 - Masking of Disease

11 - Rebound of Gastric Acid Secretion

12 - Omeprazole - Selected Adverse Events

13 - Overall Safety Conclusions

14 - References


Appendix 1

Appendix 2

FDA Background

Tab 1 - Introductory Memorandum

Tab 2 - Clinical Statistical Review of Efficacy

Key Points to Remember about GERD

Lagergren, Jesper, MD, et al, "Symptomatic Gastroesophageal Reflux a a Risk Factor for Esophageal Adenocarcinoma," New England Journal of Medicine v348, no. 11, 3/18/99, p76-79.*

Gerson, L. MD, et al, "A Cost-Effectiveness Analysis of Prescribing Strategies in the Management of Gastroesophageal Reflux Disease," American Journal of Gastroentereology, Vol. 95, no 2, 2000, p80-83.*

Katz, Philip O., MD, "Treatment of Gastroesophageal Reflux disease: Use of Algorithms to Aid in Management," American Journal of Gastroentereology, Vol. 94, no 11, September 1999, p84-85.*

Statistical Issues

Tab 3 - Pharmacodynamic Aspects of H2-Blockers versus Proton Pump Inhibitors

Tab 4 - Summary of Clinical Safety

Tab 5 - OPDRA Postmarketing Safety Review

Tab 6 - Pharmacology Summary and Review

Tab 7 - Review of Label Comprehension Study

Tab 8 - Overview of Actual Use Trials

Tab 9 - Clinical and Statistical Reviews of Actual Use Trials

Tab 10 - Review of Global Postmarketing Safety of Omeprazole Magnesium

*Contains copyrighted material which may be viewed at Dockets Management Branch, 5630 Fishers Lane, Room 1061, Rockville, Md 20852.