CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
August 14 2008 - 4:01PM
PR Newswire (US)
PALO ALTO, Calif., Aug. 14 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that it has
received approval from the European Medicines Agency (EMEA) for the
brand name Ranexa(R) (ranolazine). On July 10, 2008, the Company
announced that the EMEA had granted marketing authorization for
ranolazine in all 27 European Union (EU) member states under the
brand name Latixa. "Securing approval for the Ranexa brand name in
Europe provides important brand synergy in the world's two largest
cardiovascular markets, the U.S. and the EU," said Louis G. Lange,
M.D., Ph.D., chairman and chief executive officer of CV
Therapeutics. Ranexa is approved for use in Europe as an add-on
therapy for the symptomatic treatment of patients with stable
angina pectoris who are inadequately controlled or intolerant to
first-line antianginal therapies. The product is approved for use
in 375 mg, 500 mg and 750 mg doses, administered twice daily. About
CV Therapeutics CV Therapeutics, Inc., headquartered in Palo Alto,
California, is a biopharmaceutical company primarily focused on
applying molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics Ltd. is the 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 chronic angina in patients who have not achieved an adequate
response with other antianginal drugs, and Lexiscan(TM)
(regadenoson) injection for use as a pharmacologic stress agent in
radionuclide myocardial perfusion imaging in patients unable to
undergo adequate exercise stress. Ranexa is also approved for use
in the European Union as add-on therapy for the symptomatic
treatment of patients with stable angina pectoris who are
inadequately controlled or intolerant to first-line antianginal
therapies. Except for the historical information contained herein,
the matters set forth in this press release, including statements
as to research and development 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 operating losses and fluctuations in operating results;
capital requirements; regulatory review and approval of our
products; special protocol assessment agreement; the conduct and
timing of clinical trials; commercialization of products; market
acceptance of products; product labeling; concentrated customer
base; reliance on strategic partnerships and collaborations;
uncertainties in drug development; uncertainties regarding
intellectual property 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 June 30, 2008. CV Therapeutics
disclaims any intent or obligation to update these forward-looking
statements. DATASOURCE: CV Therapeutics, Inc. CONTACT: John Bluth,
Executive Director, Corporate Communications & Investor
Relations, CV Therapeutics, Inc., +1-650-384-8850 Web site:
http://www.cvt.com/
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