Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

July 18, 2002

Afternoon Session

NDA 21-387 PravacholŽ (pravastatin sodium) tablets co-packaged with BufferinŽ (buffered acetylsalicylic acid)


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