Merck Cozaar
Executive Summary
Heart failure indication will not be submitted to FDA for losartan following ELITE II study which found no statistically significant difference between the angiotensin-II antagonist losartan and the ACE inhibitor captopril in reducing overall deaths or in reducing sudden cardiac death and/or resuscitated cardiac arrest. Merck will request removal of the first-line indication in any country where Cozaar is approved for first-line use in heart failure. The product is approved for hypertension in the U.S
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