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FDA Will Review CV Therapeutics' Ranexa for Possible New Use
Submitted on:
11.19.2007
CV Therapeutics Inc. said Monday that the U.S. Food and Drug Administration will review its chest pain drug Ranexa, which is already approved as a treatment for chronic angina, or chest pain, in patients who have not responded to other anti-anginal drugs for use as an initial treatment of angina. CV Therapeutics also wants the label to reflect a reduction in cautionary language. Separately, the FDA will review a new drug application for Ranexa for the for use in reducing the levels of hemoglobin HbA1c in coronary artery disease patients with diabetes. The company said the FDA has agreed to make a decision on both applications on July 27, 2008.
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