Joint Meeting of the
NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
and
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
October 20, 2000
Briefing Information
NDA 21-229 Omeprazole Magnesium Tablets
Procter & Gamble Company & ASTRA Zeneca LP Briefing Documents
Disclaimer
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.
2 - Characterization of Heartburn Consumer
3 - Pathophysiology and Pharmacology
8 - Special Safety Considerations
9 - Long-Term potential for Gastro-Intestinal Cellular Alterations
11 - Rebound of Gastric Acid Secretion
12 - Omeprazole - Selected Adverse Events
13 - Overall Safety Conclusions
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.*
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.