Navigation Links
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
Date:12/7/2007

PALO ALTO, Calif., Dec. 7 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa(R) (ranolazine extended-release tablets) as part of its ongoing review of the Company's supplemental new drug application (sNDA).

This follows the FDA's acceptance of an sNDA seeking expansion to the approved product labeling for Ranexa to include a first line angina indication and a significant reduction in cautionary language as well as a separate NDA for a potential labeling change to add reduction of hemoglobin A1c (HbA1c) in coronary artery disease patients with diabetes. The two sNDAs are being reviewed by the FDA Division of Cardiovascular and Renal Products and the NDA is being reviewed by the FDA Division of Metabolism and Endocrinology Products.

The Prescription Drug User Fee Act (PDUFA) action date for the sNDAs and the NDA is July 27, 2008. The FDA has requested, and CV Therapeutics has paid three separate user fees to support the review of both sNDAs and the NDA.

"We anticipate receiving approval for first line angina use, which would significantly expand the patient population eligible to receive Ranexa, and we are very pleased that the FDA also is now evaluating separate potential anti- arrhythmic and HbA1c reduction claims for Ranexa on the same timeline," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.

In September 2007, data published in Circulation and presented at the European Society of Cardiology Congress 2007 in Vienna, Austria showed that Ranexa reduced ventricular arrhythmias in pati
'/>"/>

SOURCE CV Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. InstaCare Corp. Reviewing M&A Plans
2. Thomson Scientific Publishes its Third Quarter Issue of the Ones to Watch Reviewing the Most Promising Drugs in the Pharmaceutical Pipeline
3. DNA vaccine against multiple sclerosis appears safe, potentially beneficial
4. UCLA study identifies designer estrogen as potential MS drug
5. Office-Based Medical Treatment and Internet Resources Are Potential Solution to Rising Painkiller Misuse Among Teens, Young Adults
6. Common abdominal pain may be due to a potentially treatable newly recognized inflammatory reaction
7. Potential new approach to treat cognitive impairments in schizophrenia
8. Nosespray vaccine using aloe vera has exciting potential, researcher says
9. Network approach identifies potential breast cancer susceptibility gene
10. Liver fibrosis will be treated by a potential target
11. Researchers study potential health benefits of natural chemicals in muscadine grape seeds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/30/2015)... (PRWEB) , ... August 31, 2015 , ... ... jobs and a third of tax receipts, issues that are critically important to ... have bands of attorneys and lobbyists monitoring proposed legislation and changing tax and ...
(Date:8/30/2015)... ... August 31, 2015 , ... ... Cooking Magazine for Kids , recently elected two new officers to serve on ... further ChopChop’s mission of inspiring and teaching kids to cook real food with ...
(Date:8/30/2015)... Auckland, NZ (PRWEB) , ... August 30, 2015 ... ... enterprise collaboration across platforms and devices, today announced it is a Silver Sponsor ... 1, 2015 at Sky City Convention Centre in Auckland, NZ. Throughout the event, ...
(Date:8/30/2015)... ... 30, 2015 , ... InHealth Media ( http://www.inhealthmedia.com ) announced ... Director for InHealth Media. Mr. Spector comes with a wide array of ... on-air television, producing shows, on air-radio and media relations. , Brian joins ...
(Date:8/30/2015)... ... 30, 2015 , ... Nutritional Products International ( http://www.nutricompany.com ) ... global cosmeceutical and skin care brands. Mr. Fernandez comes with a wide ... working in operations, purchasing and management for some of the nations biggest retail ...
Breaking Medicine News(10 mins):Health News:Newport Board Group, an Advisory Firm Serving the Middle Market, Issues Five Tips on Selling Services to the Government 2Health News:Newport Board Group, an Advisory Firm Serving the Middle Market, Issues Five Tips on Selling Services to the Government 3Health News:Newport Board Group, an Advisory Firm Serving the Middle Market, Issues Five Tips on Selling Services to the Government 4Health News:ChopChop Kids Appoints New Chair and Vice-Chair to Board of Directors 2Health News:ChopChop Kids Appoints New Chair and Vice-Chair to Board of Directors 3Health News:AvePoint Showcases the Future of Enterprise Collaboration as Silver Sponsor of the Digital Workplace Conference in New Zealand 2Health News:AvePoint Showcases the Future of Enterprise Collaboration as Silver Sponsor of the Digital Workplace Conference in New Zealand 3Health News:AvePoint Showcases the Future of Enterprise Collaboration as Silver Sponsor of the Digital Workplace Conference in New Zealand 4Health News:InHealth Media Appoints New Global Communications Director 2Health News:NPI Executive Vice President Leads Cosmeceutical Expansion 2
... Dec. 4 Accuray Incorporated,(Nasdaq: ARAY ), a ... company has hired Derek Bertocci as its chief financial officer. ... been serving as the chief financial officer of BioForm,Medical, Inc., ... October 2006, will begin at Accuray on January 1,2009. , ...
... bring sports flavor to the conversation about a serious men,s health ... ... -- College basketball analyst and sports ambassador Dick Vitale and co-host ... ESPN, The V Foundation for Cancer Research® and Stand Up To ...
... Dec. 4 Decision Resources, one of the,world,s ... and,healthcare issues, finds that Eisai/Helsinn Healthcare,s Aloxi,s marketing,message ... the most influential,by oncologists in the chemotherapy-induced nausea ... with the brand,highlighting the strength of the Aloxi ...
... , VALENCIA, Calif., Dec. 4 ... has met the primary endpoints of its final two pivotal Phase 3 ... company expects to disclose more details of the top-line data from these ... and 102) by mid-December. , , ...
... about a serious men,s health threat , ... basketball analyst and sports ambassador Dick Vitale and co-host of ... with ESPN, The V Foundation for Cancer Research(R) and Stand ... discussion about the often ignored reality of prostate cancer and ...
... Inc.,(NYSE: NUS ) today announces its 2009 financial ... at 9 a.m. at the Grand Hyatt,Hotel in New York ... operational results and outline plans,for 2009. , ... and we look forward to rounding out 2008,on a positive ...
Cached Medicine News:Health News:Accuray Hires Chief Financial Officer 2Health News:Accuray Hires Chief Financial Officer 3Health News:ESPN'S Dick Vitale and Michael Wilbon Stand Up in the Fight Against Prostate Cancer 2Health News:ESPN'S Dick Vitale and Michael Wilbon Stand Up in the Fight Against Prostate Cancer 3Health News:ESPN'S Dick Vitale and Michael Wilbon Stand Up in the Fight Against Prostate Cancer 4Health News:Oncologists Rank Aloxi's Marketing Message Most Influential in the Chemotherapy-Induced Nausea and Vomiting Drug Market 2Health News:MannKind Reports Positive Results from Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes 2Health News:MannKind Reports Positive Results from Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes 3Health News:ESPN's Dick Vitale and Michael Wilbon Stand Up in the Fight Against Prostate Cancer 2Health News:ESPN's Dick Vitale and Michael Wilbon Stand Up in the Fight Against Prostate Cancer 3Health News:ESPN's Dick Vitale and Michael Wilbon Stand Up in the Fight Against Prostate Cancer 4Health News:Nu Skin Enterprises Offers 2009 Guidance During Annual Investor Day 2Health News:Nu Skin Enterprises Offers 2009 Guidance During Annual Investor Day 3
(Date:8/28/2015)... Research and Markets ( ... "Investigation Report on China,s Tobramycin Market, 2010-2019" report ... antibiotic whose eye drop and ointment are the most ... or inflammation caused by eye infection. Currently, dozens of ... to produce tobramycin, among which the Top 5 are ...
(Date:8/28/2015)... 28, 2015 Research ... addition of the "Investigation Report on China,s ... Developed by Pharmacia & Upjohn in ... which effectively reduces intraocular pressure. As the first ... the trade name of Xalatan) entered ...
(Date:8/28/2015)... Aug. 28, 2015  Perrigo Company plc ("Perrigo") (NYSE: ... completed the acquisition of leading OTC brands from GSK ... The transaction is a clear demonstration of Perrigo,s unique ... European distribution network spanning 36 countries.  ... commented, "We are excited to complete this transaction, ...
Breaking Medicine Technology:Investigation Report on China's Tobramycin Market, 2015-2019 2China Latanoprost Market Investigation Report 2015-2019 2Perrigo Completes Acquisition of Leading Portfolio of OTC Brands from GSK 2Perrigo Completes Acquisition of Leading Portfolio of OTC Brands from GSK 3Perrigo Completes Acquisition of Leading Portfolio of OTC Brands from GSK 4
... 23, 2012  AlloSource, one of the nation,s largest non-profit ... use in surgical procedures and the world,s largest processor ... Dale Bike as Vice President of Sales and Marketing. ... Sales and Marketing, Dale will lead the AlloSource direct ...
... The Academy of Managed Care Pharmacy (AMCP) has installed ... elected members: President-Elect Kim A. Caldwell and Directors David ... members on the new Board of Directors are: President ... Directors Steve Avey and Eric Cannon. All of the ...
Cached Medicine Technology:Industry Veteran Brings Sales Expertise to AlloSource's Growing Distribution Network 2Academy of Managed Care Pharmacy (AMCP) Installs 2012-2013 Board of Directors 2Academy of Managed Care Pharmacy (AMCP) Installs 2012-2013 Board of Directors 3Academy of Managed Care Pharmacy (AMCP) Installs 2012-2013 Board of Directors 4
... System is an automated multiplexing platform that ... detection, pathogen sequence detection and pharmacogenetics applications. ... applied to an open and flexible electronic ... reused until all tests sites have been ...
Cable connections for 5 different adapters: Storz, ACMI, Pentax, Wolf and Olympus....
... Mark The X & Y Coordinates At The ... Alignment. 11mm Inner Diameter & 13mm Outer Diameter ... Guess Work Associated With Hand-Held Markers By Mounting ... Housing To Ensure A More Perfect Mark. , ...
... • V-shaped bottom allows easy withdrawal ... facilitate pour-out ,• Nesting ring allows ... Basin designed for 4, 8, and 12 ... bottom permits withdrawal of practically all of ...
Medicine Products: