PALO ALTO, Calif., Aug. 14 CV Therapeutics, Inc.(Nasdaq: CVTX) today announced the U.S. Food and Drug Administration approvaland U.S. product launch of the 1000 mg tablet of Ranexa(R) (ranolazineextended-release tablets).
The approved product labeling recommends that Ranexa be initiated at 500mg twice daily (b.i.d.) and increased to 1000 mg b.i.d., as needed, based onclinical symptoms. Prior to the launch of the 1000 mg tablet, this meant thatpatients taking 1000 mg b.i.d. had to take four 500 mg Ranexa tablets per day.These patients now have the option of taking two 1000 mg tablets per day.
"We are very excited to bring the added convenience of a 1000 mg tablet tothe group of patients currently taking Ranexa at this dosage. While the 1000mg dose currently represents less than 10 percent of our business,CV Therapeutics is committed to providing new options that add value fordoctors and patients," said Lewis Stuart, senior vice president, commercialoperations.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is abiopharmaceutical company focused on applying molecular cardiology to thediscovery, development and commercialization of novel, small molecule drugsfor the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine extended-releasetablets), is indicated for the treatment of chronic angina in patients whohave not achieved an adequate response with other antianginal drugs, andshould be used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug developmentcandidates and programs, including regadenoson, which is being developed forpotential use as a pharmacologic stress agent in myocardial perfusion imagingstudies, and CVT-6883, which is being developed as a potential treatment forcardiopulmonary diseases. Regadenoson and CVT-6883 have not been determined byany regulatory authorities to be safe or effective in humans for any use.
Except for the historical information contained herein, the matters setforth in this press release, including statements as to market acceptance ofour products, are forward-looking statements within the meaning of the "safeharbor" provisions of the Private Securities Litigation Reform Act of 1995.These forward-looking statements are subject to risks and uncertainties thatmay cause actual results to differ materially, including operating losses andfluctuations in operating results; capital requirements; regulatory review andapproval of our products; special protocol assessment agreement; the conductand timing of clinical trials; commercialization of products; marketacceptance of products; product labeling; concentrated customer base; andother risks detailed from time to time in CV Therapeutics' SEC reports,including its Quarterly Report on Form 10-Q for the quarter ended June 30,2007. CV Therapeutics disclaims any intent or obligation to update theseforward-looking statements.
SOURCE CV Therapeutics, Inc.