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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

- New labeling reinforces strong safety profile of Ranexa -

- Conference call scheduled for 8:00 a.m. ET/5:00 a.m. PT -

PALO ALTO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa(R) (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.

According to the revised labeling, Ranexa is indicated for the treatment of chronic angina and may be used alone or in combination with traditional therapies for chronic angina, such as beta blockers, calcium channel blockers and nitrates, and common cardio-protective treatments for cardiovascular disease such as anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers.

Ranexa may now be used as part of an optimal medical therapy regimen for chronic angina patients, regardless of whether or not they receive a stent or other medical intervention. Ranexa does not reduce heart rate or blood pressure and, unlike long acting nitrates, Ranexa can be prescribed for patients taking oral erectile dysfunction treatments.

"This important FDA action allows the benefits of Ranexa to be extended to more patients. The new labeling clearly describes the substantial proven safety and efficacy of Ranexa for the treatment of chro
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SOURCE CV Therapeutics, Inc.
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