Navigation Links
CVT Announces That FDA Continues to Review Ranexa(R) Applications
Date:7/28/2008

--FDA to provide draft labeling in the next few weeks--

PALO ALTO, Calif., July 28 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that it is continuing its review of CV Therapeutics' pending applications for Ranexa(R) (ranolazine extended-release tablets) past the Prescription Drug User Fee Act (PDUFA) action date of July 27, 2008. The applications seek a first line angina indication and promotable claims for the reduction of hemoglobin A1c (HbA1c) and ventricular arrhythmias in patients with coronary artery disease. The FDA has informed CV Therapeutics that the Company should receive draft labeling in the next few weeks, and the Company plans to promptly communicate when the labeling is complete.

On September 27, 2007, the Company announced it had submitted a supplemental new drug application (sNDA) to the FDA seeking an expansion of the approved product labeling for Ranexa. The submitted sNDA requested 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.

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.

Following submission of the initial sNDA, the FDA initiated a separate sNDA review by the Division of Cardiovascular and Renal Products to evaluate the approval of potential anti-arrhythmic claims and a separate new drug application review by the Division of Metabolism and Endocrinology Products to evalu
'/>"/>

SOURCE CV Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2 3

Related medicine news :

1. Brookdale Announces Second Quarter 2008 Release and Earnings Call
2. Grupo Casa Saba Announces Sales and Operating Income Increased 14.05% and 13.45%, Respectively
3. Psychemedics Corporation Announces Second Quarter Results
4. American Heart Association CEO Announces Retirement
5. Klafter & Olsen LLP Announces That It Has Filed a Class Action Lawsuit Against ArthroCare Corporation on Behalf of Common Stock Holders and Certain Traders in ArthroCare Options
6. Dataline Announces Participation in Operation Golden Phoenix
7. Hoag Hospital Announces Agreement to Open Irvine Campus
8. ev3 Inc. Announces Revised Date for 2008 Second Quarter Financial Results and Conference Call
9. The Connecticut Hospice, Inc. Announces the Arrival of Six Nurse Scholars From The Henrietta Szold-Hadassah-Hebrew University School of Nursing
10. ThermoGenesis Announces 10 New BioArchive(R) System Distributors
11. Tepha Announces Appointment of John Hartnett as Executive Vice President and Chief Operating Officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2013)... In the five years through 2013, revenue ... been growing at an average annualized rate of 7.7% to ... in poultry prices as well as output growth, says IBISWorld. ... a healthier alternative to other meats. Additionally, poultry meat represents ... than the world average. And although pork is still the ...
(Date:5/25/2013)... Utah (PRWEB) May 25, 2013 Today, ... health insurance marketplaces . Zane Benefits, which provides comprehensive ... is the leader in defined contribution plans ... website, the October 1, 2013 open enrollment of the ... mantra of the Marketplaces is "Choice, Competition and Clout ...
(Date:5/25/2013)... Imagine running the air conditioner with the windows open ... wasted energy! If the home has a folding pull-down attic ... that may be just what is occurring in the home ... energy in the form of higher energy bills. Drafts are ... home. , Drafts occur through the small cracks around doors, ...
(Date:5/25/2013)... Dr. Leslie Gerstman announced today that Ultherapy ... the neck, on the brow and under the chin -- ... is a non-surgical procedure for the face and neck that ... skin over time. The use of FDA-cleared ultrasound technology enables ... the deepest support layers of the skin – typically addressed ...
(Date:5/25/2013)... Communities of Distinction TV announces ... fifth largest media market in the United States with almost ... destination in Texas and a major convention city. Ft. Worth ... as it is home to many major museums. Both cities ... to the arts. Residents and locals will be able to ...
Breaking Medicine News(10 mins):Health News:Poultry Farming Industry in China Industry Research Report – Now Available from IBISWorld 2Health News:Poultry Farming Industry in China Industry Research Report – Now Available from IBISWorld 3Health News:Zane Benefits Publishes New Information on the Health Insurance Marketplaces 2Health News:Zane Benefits Publishes New Information on the Health Insurance Marketplaces 3Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 2Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 3Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 4Health News:Dr. Leslie Gerstman Is Now Offering the Non-surgical Facelifting Procedure – Ultherapy – in NYC and NJ 2Health News:Communities of Distinction TV Presents May Air Dates for Dallas-Ft. Worth, Texas 2
... DALLAS April 19, 2011 A device developed ... of pelvic fractures with minimal postsurgical scarring, pain and ... the nation,s 200 level I trauma centers. ... Reinert developed the Starr Frame, its associated accessories and ...
... , MONDAY, April 18 (HealthDay News) -- Hospitals are ... not have hemophilia, a rare disorder in which blood does ... patients is potentially risky, according to new research. Stanford ... recombinant factor 7a, grew by 140 times from use in ...
... Gardner HealthDay Reporter , MONDAY, April 18 (HealthDay ... suicide when they live in communities where they feel they ... simply because more same-sex couples live in the area, new ... April 18 in Pediatrics , lesbian, gay and bisexual ...
... 18 (HealthDay News) -- Most people with a reduced sense of ... anything at all -- adjust and learn to cope, researchers say. ... less importance on the sense of smell in their daily lives ... included 470 people, half who either lacked or had a reduced ...
... , MONDAY, April 18 (HealthDay News) -- Healthy ... a type of blood fat associated with heart disease ... scientific statement released Monday. About one-third (31 percent) ... levels, defined as more than 150 milligrams per deciliter ...
... list, can reduce problems with recurring low back pain, reveals ... people suffer with low back pain, and most get better. ... their work, everyday and leisure activities are limited to varying ... is important that the pain be treated at an early ...
Cached Medicine News:Health News:Pelvic-repair device developed by UT Southwestern surgeons enables minimally invasive trauma surgery 2Health News:Pelvic-repair device developed by UT Southwestern surgeons enables minimally invasive trauma surgery 3Health News:Off-Label Use of Clotting Drug Soars, Report Finds 2Health News:Support May Help Curb Suicide Among Gay Youths 2Health News:Support May Help Curb Suicide Among Gay Youths 3Health News:Poor Sense of Smell Not a Big Loss for Most People: Study 2Health News:Lifestyle Changes Can Slash Blood Fat Levels, Experts Say 2Health News:Immediate treatment can alleviate future back problems 2
(Date:5/24/2013)... , May 24, 2013  An international roster ... Saturday, May 18, in Santa Monica, Calif. ... new lung-sparing therapies for MPM, a rare form of ... affects the pleura, the lining of the chest. ... and Blood Institute, the 3rd Annual International Symposium on ...
(Date:5/24/2013)... , May 24, 2013  Sinovac Biotech ... provider of biopharmaceutical products in China ... operating subsidiary company of Sinovac, obtained the Certificate ... Certificate) from the China State and Food Administration ... bulk production plants, and its Changping filing and ...
(Date:5/23/2013)... y PARÍS, 24 de mayo de ... ), un destacado desarrollador y fabricante de herramientas ... la diagnosis y tratamiento de la enfermedad vascular ... del ensayo ADVISE ( Ad enosine V ... E valuation) II durante la sesión de ensayo ...
Breaking Medicine Technology:International Mesothelioma Experts Present Promising New Research Findings at the 3rd Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma 2International Mesothelioma Experts Present Promising New Research Findings at the 3rd Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma 3Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines 2Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 4Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 5Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 6
... Uroplasty, Inc. (Nasdaq: UPI ), a ... proprietary products to treat voiding dysfunctions, today announced that ... Medicare carrier, now covers posterior tibial nerve stimulation (PTNS) ... of the symptoms of overactive bladder. Palmetto ...
... Union poised to regulate probiotics, and with probiotic supplement ... to know what they,re buying, and how these products can ... types of regulations in the U.S. As European regulations raise ... are still faced with a confusing array of immune system ...
Cached Medicine Technology:Additional Regional Medicare Carrier Initiates Coverage for Posterior Tibial Nerve Stimulation (PTNS) Delivered via Uroplasty's Urgent® PC Neuromodulation System 2Additional Regional Medicare Carrier Initiates Coverage for Posterior Tibial Nerve Stimulation (PTNS) Delivered via Uroplasty's Urgent® PC Neuromodulation System 3As Europe Regulates Probiotics, Americans Need to Know What They're Buying 2As Europe Regulates Probiotics, Americans Need to Know What They're Buying 3
PremierEdge™ Implant Knives....
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
PremierEdge™ Clear Cornea Knives - Trapezoid....
Medicine Products: