Food and Drug Administration

Cardiovascular & Renal Drugs Advisory Committee

January 17, 2002

NDA 20-757/S-021 AvaproŽ (irbesartan), Sanofi-Synthelabo (c/o Bristol-Myers squibb), for the treatment of hypertensive patients with tyep 2 diabetic renal 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, Sanofi-Synthelabo   pdf

Food and Drug Administration

Medical Review   pdf

Statistical Review   pdf  htm   doc

Bibliography   pdf   htm   doc