Food and Drug Administration

Cardiovascular & Renal Drugs Advisory Committee

January 18, 2002

NDA 21-387, Pravastatin/Aspirin, Bristol-Myers Squibb, co-package, for long-term management to reduce the risk of death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke in patients with clinically evident coronary heart disease

Briefing Information


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.

Sponsor Briefing Information

Bristol-Myers Squibb Pharmaceutical Research Institute   pdf

Appendix   pdf

Food and Drug Administration

Medical Review   pdf   htm   doc