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
Disclaimer
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