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
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth