CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
September 27 2007 - 4:01PM
PR Newswire (US)
PALO ALTO, Calif., Sept. 27 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the Company
has submitted a supplemental new drug application (sNDA) to the
U.S. Food and Drug Administration (FDA) seeking an expansion to the
approved product labeling for Ranexa(R) (ranolazine
extended-release tablets). The submitted sNDA requests a new
indication for first line treatment of chronic angina and a
significant reduction in cautionary language, based on substantial
data from the MERLIN TIMI-36 study. "We believe that this new
labeling, if approved, should position Ranexa as safe and effective
for use in a broader population," said Louis G. Lange, CV
Therapeutics chairman and chief executive officer. In accordance
with a special protocol assessment agreement between the FDA and CV
Therapeutics, the Company believes that data from the MERLIN
TIMI-36 study could support expansion of the existing Ranexa
indication to first line angina. 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.
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 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, 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, including statements as to
regulatory filings and special protocol assessment agreements, 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; 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: Investors or
Media, 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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