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Ranexa

Generic name: ranolazine
Treatment for: Angina

Update: Ranexa Now FDA Approved - January 27, 2006

CV Therapeutics Submits Amendment to Ranexa (ranolazine)


New Drug Application Seeking FDA Approval for Treatment of Chronic Angina

PALO ALTO, Calif., July 27, 2005 -- CV Therapeutics, Inc. announced today that it has submitted an amendment to the new drug application (NDA) for Ranexa (ranolazine) to the U.S. Food and Drug Administration (FDA) seeking approval for the treatment of chronic angina in a restricted patient population.

This amendment is intended to provide a complete response to the approvable letter received in October 2003, based on results from the recently completed Evaluation of Ranolazine In Chronic Angina (ERICA) study, which was conducted under the FDA's special protocol assessment (SPA) process and met its primary endpoint.

The NDA, if approved, could enable the potential launch of Ranexa in a restricted patient population in the first half of 2006. The complete NDA, as amended, now includes data from three Phase 3 studies: ERICA, CARISA and MARISA.

"After receiving positive ERICA data in April, our team has worked extremely hard to integrate the new data into an NDA amendment. We look forward to working with the FDA on the potential approval of Ranexa," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.

If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.4 million people in the United States.

Posted: July 2005

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