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FDA Approves Ranexa(R) for First Line Anti Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia, New Atrial Fibrillation and HbA1c
Date:11/6/2008

nic angina, the debilitating cardiac chest pain that affects more than nine million Americans each year," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.

"Ranexa is a very well tolerated drug that can now be considered among the first drugs to be given to patients with chronic angina. Our commercial organization will actively focus on educating new and existing prescribers about these significant new labeling improvements," Lange added.

The most frequently reported adverse reactions during treatment with Ranexa in clinical trials were dizziness, headache, constipation and nausea. Complete updated prescribing information will be available at http://www.ranexa.com.

"Ranolazine may now take optimal medical therapy to an entirely new level, and may afford enhanced symptom relief," said Dr. William Boden, clinical chief, division of cardiovascular medicine, University at Buffalo Schools of Medicine & Public Health and principal investigator of the COURAGE study. "I have seen excellent safety, tolerability and symptom relief in the great majority of chronic angina patients for whom I have prescribed ranolazine," he added.

"As we have seen in the MERLIN-TIMI 36 trial and in clinical practice, patients with ischemia and angina can be at increased risk for arrhythmias and also often have diabetes. Considering its mechanism of action, established cardiovascular safety and observed reductions in arrhythmias and HbA1c, ranolazine now becomes an even more important drug in our treatment of chronic angina," said Dr. Eugene Braunwald, Distinguished Hersey Professor of Medicine at Harvard Medical School and chairman of the TIMI Study Group.

These significant new labeling changes were supported by a supplemental new drug application submitted in September 2007 that included data from the 6,560 patient MERLIN-TIMI 36 trial, which showed no adverse trend in death or arrhythm
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SOURCE CV Therapeutics, Inc.
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