First-line indication for Avalide

FDA approves Bristol-Myers Squibb's Avalide (irbesartan/hydrochlorothiazide) Nov. 16 for first-line use in patients who are likely to need multiple drugs to achieve their blood pressure goals. The indication was unanimously supported by FDA's Cardio-Renal Advisory Committee (1"The Pink Sheet" April 23, 2007, p. 11). The approval reflects a shift in agency thinking toward more aggressive first-line treatment of hypertension with combination products (2"The Pink Sheet" April 23, 2007, p. 22). Other combination drugs approved for initial treatment include Bristol-Myers Squibb's Capozide (captopril/HCTZ), Barr's Ziac (bisoprolol/HCTZ) and Merck's Hyzaar (losartan/HCTZ)...