Navigation Links
CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)

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:
(Date:11/24/2015)... DIEGO , Nov. 24, 2015 Halozyme Therapeutics, Inc. ... Healthcare Conference in New York on Wednesday, ... Helen Torley , president and CEO, will provide a corporate ... New York at 1:00 p.m. ET/10:00 a.m. PT ... and investor relations, will provide a corporate overview. --> ...
(Date:11/24/2015)... QUEBEC CITY , Nov. 24, 2015 /PRNewswire/ - ... the request of IIROC on behalf of the Toronto ... this news release there are no corporate developments that ... price. --> --> ... --> . --> Aeterna Zentaris ...
(Date:11/24/2015)... IN (PRWEB) , ... November 24, 2015 , ... The ... newest Special Interest Group (SIG), MultiGP, also known as Multirotor Grand Prix, to represent ... the last few years. Many AMA members have embraced this type of racing and ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna ... announced today that the remaining 11,000 post-share consolidation ... Purchase Warrants (the "Series B Warrants") subject to ... exercised on November 23, 2015, which will result ... After giving effect to the issuance of such ...
Breaking Biology Technology:
(Date:10/29/2015)... --  MedNet Solutions , an innovative SaaS-based eClinical technology ... is pleased to announce that it has been selected ... of only three finalists for a 2015 Tekne ... category. The Tekne Awards honor Minnesota ... and leadership. iMedNet™ eClinical  technology ...
(Date:10/29/2015)... , Oct. 29, 2015  Rubicon Genomics, Inc., ... U.S. distribution of its DNA library preparation products, ... Rubicon,s new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq has ... preparation of NGS libraries for liquid biopsies--the analysis ... and prognostic applications in cancer and other conditions. ...
(Date:10/29/2015)... 2015 Today, LifeBEAM , a ... 2XU, a global leader in technical performance sports ... with advanced bio-sensing technology. The hat will allow ... key biometrics to improve overall training performance. As ... will bring together the most advanced technology, extensive ...
Breaking Biology News(10 mins):