Navigation Links
FDA Approves New Mechanism of Action Labeling for Ranexa(R)
Date:12/18/2007

PALO ALTO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has approved new language for the product labeling for Ranexa(R) (ranolazine extended-release tablets) which describes the ability of ranolazine to inhibit the late sodium current at therapeutic levels.

Published data on ranolazine's mechanism suggests that during ischemic episodes excess sodium can flow into cardiac cells through sodium channels. This excess sodium can trigger a subsequent overload of calcium that can lead to problems with proper contraction and relaxation of the heart. Late sodium current inhibition has been shown to improve mechanical and electrical dysfunctions of cardiac cells under these circumstances.

"We believe it is important for physicians to have as much information as possible on the mechanism of action for Ranexa and we are very pleased that the FDA has worked with us to add this new language to the approved product labeling," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.

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. Complete product labeling is available at http://www.cvt.com.

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.


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

Related biology technology :

1. Brazilian National Biosafety Technical Committee Approves Monsanto Company Insect-Protected Corn Trait
2. FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
3. FDA Approves ACAM2000(TM) Vaccine for Protection Against Smallpox
4. NJ Board of Pharmacy Approves Wedgewood Pharmacy Technician-Training Program
5. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
6. FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)
7. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir
8. FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
9. FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
10. FDA Approves Genzymes Renvela(TM) for Dialysis Patients
11. FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 09, 2016 , ... Creation Technologies, leading global provider ... Overall Customer Rating Award from Circuits Assembly , today announced its milestone achievement ... Canada, Mexico and China. , The EMS provider, known in the EMS industry ...
(Date:2/9/2016)... ... ... Date and time: March 1, 2016, 5:30 p.m. to ... of Bucks County, 3805 Old Easton Road, Doylestown, PA 18902. , The Baruch ... house for participants to learn about a new Master of Biomedical Science (MBS) ...
(Date:2/9/2016)... , ... February 09, 2016 , ... Tunnell Consulting, Inc. ... Based in Paris, he will focus on acquiring new accounts and work closely with ... , “Fred brings to our European clients more than 15 years of ...
(Date:2/9/2016)... ... 2016 , ... PharmApprove announced today the hiring ... for Rare Disorders (NORD). Dorman will lead PharmApprove efforts to work with patients, ... drug regulatory review process. , “Adding Diane Dorman is just the latest in ...
Breaking Biology Technology:
(Date:2/8/2016)... Republic , February 8, 2016 ... global payment platform which presents innovation for clients, ... Authentication feature called VoiceKey. --> Worldcore ... which presents innovation for clients, comfort and unbeatable ... VoiceKey. --> Worldcore is ...
(Date:2/3/2016)... February 3, 2016 --> ... research report "Automated Fingerprint Identification System Market by Component ... Application (Banking & Finance, Government, Healthcare, and Transportation) and ... the market is expected to be worth USD 8.49 ... between 2015 and 2020. The transformation and technology evolution ...
(Date:2/2/2016)... NEW YORK , Feb. 2, 2016 /PRNewswire/ ... analysis of the bioinformatic market by reviewing the ... computer enabled tools that drive the field forward. ... report to: Identify the challenges and opportunities ... service providers and software solution developers, as well ...
Breaking Biology News(10 mins):