Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

December 8, 2003

Briefing Information

Briefing Book - Primary Prevention of Myocardial Infarction in Those Individuals at Sufficient Risk, Bayer HealthCare LLC (HTM) (PDF) (Word)

List if Apendices (HTM) (PDF) (Word)

Appendix 1. Aspirin Professional Labeling (PDF)

Appendix 1. Proposed Labeling (HTM) (PDF) (Word)

Appendix 2. Aspirin® in Cardiovascular Indications Including Primary Prevention Indications (HTM) (PDF) (Word)

Appendix 3. Coronary Disease Risk Predicton Score Sheet for Women Based on Total Cholesterol Level (PDF)

Bibliography, Bayer HealthCare LLC (HTM) (PDF) (Word)

Background Package, Table of Contents, FDA (HTM) (PDF) (Word)

Tab 1. Cover Letters (PDF)

Tab 1. Action Requsted (PDF)

Tab 1. Statement of Grounds (PDF)

Evaluation of Aspirin Safety (PDF)

Risk/Benefit Evaluation (PDF)

Current U.S. Cardiovascular Indications (PDF)

Cardiovascular Indications Worldwide (PDF)

Third Party Recommendations-Aspirin for Cardiovascular Primary (PDF)

Tab 1. Bibliography, FDA (HTM) (PDF) (Word)

Proposed Labeling, FDA (PDF)

References, FDA (PDF)

CFR 21, Part 343 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The -Counter Human Use (PDF)

Dosage and Administration Chart (PDF)

Minutes, October 5-6, 1989 Committee Meeting (PDF)

Minutes, January 23, 1997 Committee Meeting (PDF)

Federal Register Notice, Over-The -Counter Drugs, July 8, 1977 (PDF)

Federal Register Notice, Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Notice of Proposed Rulemaking, November 16, 1988 (PDF)

Federal Register Notice, Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph, June 13, 1996 (PDF)

Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for over-tht-Counter Human Use, Final Rule for Professional labeling of Aspirin, Buffered Aspirin, and Aspirin in Combination With Antacid Drug Products, October 23, 1998 (PDF)

Medical Officer's Review of the Final Report on the Aspirin Component of the Ongoing Physicians' Health Study (PDF)

Reviews of Citizen's Petition (PDF)