Navigation Links
CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
Date:9/27/2007

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.


'/>"/>
SOURCE CV Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Canadian firm buys Proventiv Therapeutics, makes ex-Bone Care exec CEO
2. A Versatile Power Supply for All Electrophoresis Applications
3. Highest Possible Transformation Efficiencies for High-Throughput Applications
4. Unique DNA Polymerase Formulation Excels in a Broad Range of PCR Applications
5. High-Throughput System Generates Ultra-Pure PCR Products Suitable for All Applications
6. An Assessment of the Eppendorf twin.tec plate performance in PCR* applications
7. Principles and applications of electrical cell fusion
8. Eppendorf Electroporation Application Notes Your participation is highly welcome !!!
9. Optimizing Büchi® Rotary Evaporator Applications
10. Principles and applications of electrical cell fusion
11. Eppendorf Electroporation Application Notes Your participation is highly welcome !!!
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/20/2017)... ... July 20, 2017 , ... Dr. Asher Kimchi, Founder and ... of the 2017 IAC Awards at the 22nd World Congress on Heart Disease held ... four faculty to receive the Distinguished Fellowship Awards. , Dr. Asher Kimchi, together with ...
(Date:7/20/2017)... ... July 20, 2017 , ... VIC Technology Venture Development™ ... board of directors. This addition continues to strengthen and diversify VIC’s board. , ... and Chairman. “He is a highly accomplished business executive with a broad range of ...
(Date:7/20/2017)... DENVER and PLYMOUTH, Minn., July 20, 2017 ... LLC , a personalized genetic evaluations company, today ... under their partnership investigating a genetic mutation implicated ... to extend the partnership for a second case ... Last year, the KCNQ2 Cure Alliance and Pairnomix ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... ... solution to make clinical trial sites and study participants truly unified. TrialKit, a ... compliant (FDA 21 CFR Part 11) research studies entirely on mobile devices. With ...
Breaking Biology Technology:
(Date:4/19/2017)... ALBANY, New York , April 19, 2017 /PRNewswire/ ... highly competitive, as its vendor landscape is marked by ... in the market is however held by five major ... and Safran. Together these companies accounted for nearly 61% ... majority of the leading companies in the global military ...
(Date:4/11/2017)... GARDENS, Fla. , April 11, 2017 /PRNewswire/ ... management and secure authentication solutions, today announced that ... by Intelligence Advanced Research Projects Activity (IARPA) to ... IARPA,s Thor program. "Innovation has been ... and IARPA,s Thor program will allow us to ...
(Date:4/5/2017)... , April 5, 2017  The Allen Institute for ... Cell Explorer: a one-of-a-kind portal and dynamic digital window ... imaging data, the first application of deep learning to ... stem cell lines and a growing suite of powerful ... for these and future publicly available resources created and ...
Breaking Biology News(10 mins):