FDA Approves Ranexa
PALO ALTO, Calif., January 27, 2006 -- CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ranexa (ranolazine extended-release tablets).
The approved indication is as follows: Ranexa is indicated for the treatment of chronic angina. Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs. Ranexa should be used in combination with amlodipine, beta blockers or nitrates. The effect on angina rate or exercise tolerance appeared to be smaller in women than men.
The approval of Ranexa marks the first new pharmaceutical approach to treat angina in more than 20 years in the United States. CV Therapeutics anticipates that Ranexa will be available in pharmacies in late March.
"Patients will now have access to a new angina therapy for the first time in decades," said Louis G. Lange, M.D., Ph.D., CV Therapeutics chairman and chief executive officer. "CV Therapeutics is very proud to have succeeded in bringing this innovative new product to the market, and we look forward to educating cardiology specialists about Ranexa."
Source: CV Therapeutics, Inc.
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