FDA Accepts Ranexa(R) sNDA and NDA for Filing
November 19 2007 - 4:01PM
PR Newswire (US)
PALO ALTO, Calif., Nov 19 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the U.S. Food
and Drug Administration (FDA) has notified the Company that its
supplemental new drug application (sNDA) and new drug application
(NDA) for Ranexa(R) (ranolazine extended- release tablets) have
both been accepted for filing. The Prescription Drug User Fee Act
(PDUFA) action date for both applications is July 27, 2008. The
sNDA seeks an expansion to the approved product labeling for
Ranexa(R) (ranolazine extended-release tablets) to include a first
line angina indication and a significant reduction in cautionary
language. The sNDA is being reviewed by the FDA Division of
Cardiovascular Renal Products. After receiving this sNDA submission
from CV Therapeutics, the FDA initiated, and has now accepted for
filing, a separate NDA on behalf of the Company to provide a
clinical review of a potential labeling change to add reduction of
hemoglobin A1c (HbA1c) in coronary artery disease patients with
diabetes. This NDA is being reviewed by the FDA Division of
Metabolism and Endocrinology Products. "With the Ranexa sNDA and
NDA now accepted for filing, the NDA under review for regadenoson
and our marketing authorization application for ranolazine under
review in Europe, we are very excited to have several major
applications in process and are looking forward to multiple
potential approvals in 2008," 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' 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 of Corporate Communications
& Investor Relations for CV Therapeutics, Inc., +1-650-384-8850
Web site: http://www.cvt.com/
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