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On July 10, 2008, the Company announced that the EMEA had grantedmarketing authorization for ranolazine in all 27 European Union (EU) memberstates under the brand name Latixa.
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"Securing approval for the Ranexa brand name in Europe provides importantbrand synergy in the world's two largest cardiovascular markets, the U.S. andthe EU," said Louis G. Lange, M.D., Ph.D., chairman and chief executiveofficer of CV Therapeutics.
Ranexa is approved for use in Europe as an add-on therapy for thesymptomatic treatment of patients with stable angina pectoris who areinadequately controlled or intolerant to first-line antianginal therapies. Theproduct is approved for use in 375 mg, 500 mg and 750 mg doses, administeredtwice daily.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is abiopharmaceutical company primarily focused on applying molecular cardiologyto the discovery, development and commercialization of novel, small moleculedrugs for the treatment of cardiovascular diseases. CV Therapeutics Ltd. isthe company's European subsidiary based in the United Kingdom.
CV Therapeutics' approved products in the United States include Ranexa(R)(ranolazine extended-release tablets), indicated for the treatment of chronicangina in patients who have not achieved an adequate response with otherantianginal drugs, and Lexiscan(TM) (regadenoson) injection for use as apharmacologic stress agent in radionuclide myocardial perfusion imaging inpatients unable to undergo adequate exercise stress. Ranexa is also approvedfor use in the European Union as add-on therapy for the symptomatic treatmentof patients with stable angina pectoris who are inadequately controlled orintolerant to first-line antianginal therapies.
Except for the historical information contained herein, the matters setforth in this press release, including statements as to research anddevelopment and commercialization of products, are forward-looking statementswithin the meaning of the "safe harbor" provisions of the Private SecuritiesLitigation Reform Act of 1995. These forward-looking statements are subject torisks and uncertainties that may cause actual results to differ materially,including operating losses and fluctuations in operating results; capitalrequirements; regulatory review and approval of our products; special protocolassessment agreement; the conduct and timing of clinical trials;commercialization of products; market acceptance of products; productlabeling; concentrated customer base; reliance on strategic partnerships andcollaborations; uncertainties in drug development; uncertainties regardingintellectual property and other risks detailed from time to time inCV Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q forthe quarter ended June 30, 2008. CV Therapeutics disclaims any intent orobligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.