Healthcare Industry News: regadenoson
News Release - March 10, 2006
CV Therapeutics Begins Shipments of Ranexa to WholesalersPALO ALTO, Calif., March 10 (HSMN NewsFeed) -- CV Therapeutics, Inc. (Nasdaq: CVTX ) announced today that the company has begun filling orders and shipping Ranexa(TM) (ranolazine extended-release tablets) to pharmaceutical wholesalers.
CV Therapeutics anticipates that Ranexa will be available in pharmacies by late March, when the company's cardiovascular sales force expects to begin calling on cardiology specialists.
On January 27, 2006, the U.S. Food and Drug Administration approved Ranexa for marketing in the United States. The approval of Ranexa marks the first new pharmaceutical approach to treat angina in more than 20 years in the United States. Ranexa has antianginal and anti-ischemic effects that do not depend upon reductions in heart rate or blood pressure.
According to the approved product labeling, 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 antianginal 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. Complete prescribing information for Ranexa, including detailed safety and dosage information, is available at www.ranexa.com.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.
CV Therapeutics' approved products include Ranexa(TM) (ranolazine extended-release tablets) and ACEON® (perindopril erbumine) Tablets. Ranexa is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. In addition, CV Therapeutics co-promotes ACEON®, an ACE inhibitor, for reduction of the risk of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease and treatment of essential hypertension.
CV Therapeutics also has other clinical and preclinical drug development candidates and programs, including regadenoson, which is being developed for potential use as a pharmacologic stress agent in myocardial perfusion imaging studies. regadenoson has not been approved for marketing by any regulatory authorities.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to regulatory review and approval and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; special protocol assessment agreements; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.
Source: CV Therapeutics
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