FDA Approves New Mechanism of Action Labeling for Ranexa(R)
December 18 2007 - 4:10PM
PR Newswire (US)
PALO ALTO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the U.S. Food
and Drug Administration (FDA) has approved new language for the
product labeling for Ranexa(R) (ranolazine extended-release
tablets) which describes the ability of ranolazine to inhibit the
late sodium current at therapeutic levels. Published data on
ranolazine's mechanism suggests that during ischemic episodes
excess sodium can flow into cardiac cells through sodium channels.
This excess sodium can trigger a subsequent overload of calcium
that can lead to problems with proper contraction and relaxation of
the heart. Late sodium current inhibition has been shown to improve
mechanical and electrical dysfunctions of cardiac cells under these
circumstances. "We believe it is important for physicians to have
as much information as possible on the mechanism of action for
Ranexa and we are very pleased that the FDA has worked with us to
add this new language to the approved product labeling," said Louis
G. Lange, CV Therapeutics chairman and chief executive officer.
Ranexa is currently 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. Complete product labeling is
available at http://www.cvt.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 product, Ranexa(R) (ranolazine
extended-release tablets), 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. CV
Therapeutics' clinical and preclinical drug development candidates
and programs include regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial
perfusion imaging studies, and CVT-6883, which is being developed
as a potential treatment for cardiopulmonary diseases. Regadenoson
and CVT-6883 have not been determined by any regulatory authorities
to be safe or effective in humans for any use. Except for the
historical information contained herein, the matters set forth in
this press release 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, 2007. 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 of CV Therapeutics, Inc., +1-650-384-8850
Web site: http://www.cvt.com/
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