CVT Announces That FDA Continues to Review Ranexa(R) Ap...( --FDA to provide draft labe...),Health

--FDA to provide draft labeling in the next few weeks--

PALO ALTO, Calif., July 28 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that it is continuing its review of CV Therapeutics' pending applications for Ranexa(R) (ranolazine extended-release tablets) past the Prescription Drug User Fee Act (PDUFA) action date of July 27, 2008. The applications seek a first line angina indication and promotable claims for the reduction of hemoglobin A1c (HbA1c) and ventricular arrhythmias in patients with coronary artery disease. The FDA has informed CV Therapeutics that the Company should receive draft labeling in the next few weeks, and the Company plans to promptly communicate when the labeling is complete.

On September 27, 2007, the Company announced it had submitted a supplemental new drug application (sNDA) to the FDA seeking an expansion of the approved product labeling for Ranexa. The submitted sNDA requested a new indication for first line treatment of chronic angina and a significant reduction in cautionary language, based on substantial data from the MERLIN TIMI-36 study.

In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the Company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina.

Following submission of the initial sNDA, the FDA initiated a separate sNDA review by the Division of Cardiovascular and Renal Products to evaluate the approval of potential anti-arrhythmic claims and a separate new drug application review by the Division of Metabolism and Endocrinology Products to evalu
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