Food and Drug Administration
Cardiovascular and Renal Drugs Advisory Committee
July 18, 2002
Afternoon Session
NDA 21-387 Pravachol® (pravastatin sodium) tablets co-packaged with Bufferin® (buffered acetylsalicylic acid)
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.
Background Information, Bristol-Myers Squibb pdf
Bibliography pdf
Food and Drug Administration Briefing Information
Primary Medical Review, May 8, 2002 submitted NDA resubmission pdf htm doc
Primary Medical Review, June 22, 2002 submitted original NDA resubmission pdf htm doc
Clinical Pharmacology and Biopharmaceutics Review pdf htm doc