Joint Meeting of

Joint Meeting of

NONPRESCRIPTION DRUGS ADVISORY COMMITTEE

and

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

July 14, 2000

Pravachol NDA21-198, Pravastatin Sodium, 10mg

Bristol-Myers Squibb

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.

Executive Summary & Briefing Book

Appendices Table of Contents

Appendix A Current Rx Package Insert for Pravachol Tablets

Appendix B Post Marketing Surveillance: Table and Summary of Deaths

Appendix C Post Marketing Surveillance: Overdose Reports; Council for International Organization of Medical Science

Appendix D Post Marketing Surveillance: Summaries of Serious Adverse Event Reports; Hepatic Failure, Jaundice, and Hepatitis

Appendix E 10mg Dose Response Studies: Summaries of Efficacy Results

Appendix F PREDICT: Abbreviated Written Consent Form

Appendix G PREDICT: Summary of Serious Adverse Events

Appendix H PREDICT/OPTIONS: Starter Kit Elements

Appendix I PREDICT/OPTIONS: PRAVACARE Educational Program Materials

Appendix J OPTIONS: Summary of Serious Adverse Events

Appendix K Schematic Flow Chart for Toll Free Information Line