CVT Announces That FDA Continues to Review Ranexa(R) Applications
July 28 2008 - 7:00AM
PR Newswire (US)
--FDA to provide draft labeling in the next few weeks-- PALO ALTO,
Calif., July 28 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
(NASDAQ:CVTX) announced today that it has been informed by the U.S.
Food and Drug Administration (FDA) that it is continuing its review
of CV Therapeutics' pending applications for Ranexa(R) (ranolazine
extended-release tablets) past the Prescription Drug User Fee Act
(PDUFA) action date of July 27, 2008. The applications seek a first
line angina indication and promotable claims for the reduction of
hemoglobin A1c (HbA1c) and ventricular arrhythmias in patients with
coronary artery disease. The FDA has informed CV Therapeutics that
the Company should receive draft labeling in the next few weeks,
and the Company plans to promptly communicate when the labeling is
complete. On September 27, 2007, the Company announced it had
submitted a supplemental new drug application (sNDA) to the FDA
seeking an expansion of the approved product labeling for Ranexa.
The submitted sNDA requested 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. 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. Following
submission of the initial sNDA, the FDA initiated a separate sNDA
review by the Division of Cardiovascular and Renal Products to
evaluate the approval of potential anti-arrhythmic claims and a
separate new drug application review by the Division of Metabolism
and Endocrinology Products to evaluate the approval of potential
HbA1c reduction claims in patients with coronary artery disease.
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 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.
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 March 31, 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 of CV Therapeutics, Inc., +1-650-384-8850 Web site:
http://www.cvt.com/
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