Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 2/24, from 8 a.m. to 5 p.m. at the CDER Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. The committee will discuss three AstraZeneca supplemental new drug applications to an approved NDA for its hypertensive Atacand (candesartan cilexetil) tablets (4 mg, 8 mg, 16 mg, and 32 mg), to treat patients with congestive heart failure, specifically in the following ways: (1) reducing the risk of cardiovascular mortality or heart failure hospitalization when added to an angiotensin-converting enzyme inhibitor-containing regimen in patients with left ventricular systolic dysfunction; (2) reducing the risk of cardiovascular mortality or heart failure hospitalization in patients with left ventricular systolic dysfunction, as a primary renin-angiotensin-aldosterone system modulating treatment; and (3) reducing the frequency of hospitalizations for heart failure in patients with preserved left ventricular systolic dysfunction. Contact Cathy Groupe, (301) 827-7001. To view this notice, click here.
