Merck Cozaar cough advantage over ACE inhibitors labeling claim approved Dec. 29.
Executive Summary
MERCK COZAAR COUGH ADVANTAGE OVER ACE INHIBITORS LABELING CLAIM approved by FDA Dec. 29. The antihypertensive Cozaar (losartan), the first angiotensin II inhibitor to reach the market, was approved April 14 ("The Pink Sheet" April 17, 1995, p. 22). Merck submitted two studies of the cough side effect as a supplemental NDA (20-386/S-001) in February.