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Article: FDA Advisory Committee Recommends Approval of a New Indication for COZAAR-R- Based on Results of LIFE Trial.
- Article from:
- Business Wire
- Article date:
- January 6, 2003
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Business Editors/Health & Pharmaceuticals Writers
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan. 6, 2003
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today recommended approval of a new indication for COZAAR (losartan potassium tablets), Merck & Co., Inc.'s antihypertension drug, based on data from the LIFE study, which included a significant reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy (LVH)(1).
The Advisory Committee's recommendation, which is not binding on the FDA, did not provide specific language for the new indication. Merck had proposed ...