Avalide advisory committee

Executive Summary

FDA's Cardio-Renal Drugs Advisory Committee will meet April 18 to review an sNDA for Bristol-Myers Squibb's antihypertensive agent Avalide. Bristol is seeking approval for first-line use of Avalide, a combination of Bristol's angiotensin II receptor blocker Avapro and the diuretic hydrochlorothiazide, in hypertensive patients unlikely to achieve blood pressure goals on one drug. The committee will be asked to consider what constitutes adequate data to support such a claim and how the information can be most usefully displayed in the labeling. Avalide was approved by FDA in August 1998 (1"The Pink Sheet" May 17, 1999, p. 25). The meeting will be held at the CDER advisory committee conference room, 5630 Fishers Lane, Rockville, Md., beginning at 8 a.m...