CV Therapeutics Begins Shipments of Ranexa to Wholesalers
March 10 2006 - 7:00AM
PR Newswire (US)
PALO ALTO, Calif., March 10 /PRNewswire-FirstCall/ -- 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 http://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(R) (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(R), 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.
DATASOURCE: CV Therapeutics, Inc. CONTACT: investors, Christopher
Chai, Vice President, Treasury and Investor Relations,
+1-650-384-8560, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, both of CV Therapeutics, Inc. Web
site: http://www.cvt.com/
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