Navigation Links
FDA Accepts Ranexa(R) sNDA and NDA for Filing
Date:11/19/2007

PALO ALTO, Calif., Nov 19 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its supplemental new drug application (sNDA) and new drug application (NDA) for Ranexa(R) (ranolazine extended- release tablets) have both been accepted for filing. The Prescription Drug User Fee Act (PDUFA) action date for both applications is July 27, 2008.

The sNDA seeks an expansion to the approved product labeling for Ranexa(R) (ranolazine extended-release tablets) to include a first line angina indication and a significant reduction in cautionary language. The sNDA is being reviewed by the FDA Division of Cardiovascular Renal Products.

After receiving this sNDA submission from CV Therapeutics, the FDA initiated, and has now accepted for filing, a separate NDA on behalf of the Company to provide a clinical review of a potential labeling change to add reduction of hemoglobin A1c (HbA1c) in coronary artery disease patients with diabetes. This NDA is being reviewed by the FDA Division of Metabolism and Endocrinology Products.

"With the Ranexa sNDA and NDA now accepted for filing, the NDA under review for regadenoson and our marketing authorization application for ranolazine under review in Europe, we are very excited to have several major applications in process and are looking forward to multiple potential approvals in 2008," 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
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
2. FDA Accepts Sucampos sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
3. Ranexa(R) Added to New ACC/AHA Guidelines on Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI)
4. Circulation Publishes MERLIN TIMI-36 Data Showing Safety and Anti-Arrhythmic Effects of Ranexa(R)
5. CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
6. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
7. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
8. Codexis Licenses New Drug Metabolite Profiling and Lead Diversification Technology From the California Institute of Technology
9. 3 strikes, youre out? Refiling of Amendment to Change Constitution to Criminalize Stem Cell Cures Shows Trouble with Anti-Cures Cause
10. Prana Announces Filing of Annual Report
11. AMDL Announces Filing of Extension on Third Quarter 2007 Form 10-QSB
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 19, 2014  Nektar Therapeutics (NASDAQ: ... characterizing the analgesic profiles of a series of ... agonist molecules. The preclinical research candidates were created ... The analgesic properties of kappa receptor ... 1,2 Kappa opioid receptors are expressed in ...
(Date:9/19/2014)... Dublin ... announced the addition of the  "Micro Market Monitor ... offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , , ... fastest-growing segments in the chromatography market. The market ... expected to reach $2.0 billion by 2019, at ...
(Date:9/18/2014)... LONDON , Sept. 18, 2014 ... near-patient testing, is performed outside a clinical laboratory. ... hence in administrating appropriate treatments and medication. POCT ... and prevalence of lifestyle diseases such as diabetes, ... and user-friendly. POCT devices are standardized to minimize ...
(Date:9/18/2014)... (PRWEB) September 18, 2014 Texas ... John Sharp, Texas A&M Health Science Center CEO ... Department of Health and Human Services (HHS), State ... a national pandemic influenza vaccine manufacturing facility in ... an anchor for the Texas A&M Biocorridor – ...
Breaking Biology Technology:Nektar Presents Positive Preclinical Data on Oral, Peripherally-Acting Kappa Agonist Molecules at 2014 American Academy of Pain Management Meeting 2Nektar Presents Positive Preclinical Data on Oral, Peripherally-Acting Kappa Agonist Molecules at 2014 American Academy of Pain Management Meeting 3Nektar Presents Positive Preclinical Data on Oral, Peripherally-Acting Kappa Agonist Molecules at 2014 American Academy of Pain Management Meeting 4Nektar Presents Positive Preclinical Data on Oral, Peripherally-Acting Kappa Agonist Molecules at 2014 American Academy of Pain Management Meeting 5Micro Market Monitor : Global Pre-packed Chromatography Columns 2POCT Market in China 2014-2018 2Texas A&M Dedicates National Pandemic Influenza Vaccine Manufacturing Facility, on Track for 2016 Start-Up Phase 2Texas A&M Dedicates National Pandemic Influenza Vaccine Manufacturing Facility, on Track for 2016 Start-Up Phase 3Texas A&M Dedicates National Pandemic Influenza Vaccine Manufacturing Facility, on Track for 2016 Start-Up Phase 4
... ... PharmSource Information Services, Inc. announces the publication of a ... How to Minimize Your Risk." This incisive resource provides guidelines on ... risk for companies doing business throughout the world. "The U.S. Foreign ...
... SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 ... Lilly and Company (NYSE: LLY ) and Alkermes, ... New Drug Application (NDA) for exenatide once weekly has been ... (FDA). , , Exenatide once weekly is an investigational ...
... Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: ... Sun Pharmaceutical Industries Ltd. (Sun Pharma), immediately following Sun ... Drug Administration (FDA) for its Abbreviated New Drug Application ... tablets are an androgen receptor inhibitor indicated for use ...
Cached Biology Technology:PharmSource Releases White Paper on Role of U.S. Foreign Corrupt Practices Act (FCPA) in the Bio/Pharma Industry 2PharmSource Releases White Paper on Role of U.S. Foreign Corrupt Practices Act (FCPA) in the Bio/Pharma Industry 3New Drug Application for Exenatide Once Weekly Accepted for Review by FDA 2New Drug Application for Exenatide Once Weekly Accepted for Review by FDA 3New Drug Application for Exenatide Once Weekly Accepted for Review by FDA 4New Drug Application for Exenatide Once Weekly Accepted for Review by FDA 5New Drug Application for Exenatide Once Weekly Accepted for Review by FDA 6Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Casodex(R) Tablets 2
(Date:9/18/2014)... A team of researchers from McGill University and ... form of polyethylene ,microbeads, Canadian Journal of ... likely originate from cosmetics, household cleansers, or industrial ... abrasives. Owing to their small size and buoyancy, ... Microplastics are a global contaminant in the ...
(Date:9/18/2014)... DNA, tiny strands of nucleic acid that contain instructions ... genetic data, our DNA is copied into RNA molecules, ... tasks in our cells. , Several years ago, ... all other known RNAs, this molecule is circular, and ... little has been known about how they are produced. ...
(Date:9/18/2014)... from several disciplines will be celebrated tonight at the ... in improving the health of premature infants and in ... The researchers, whose work was supported by the National ... former Atomic Energy Commission, will be honored at a ... A bipartisan group of Members of Congress will be ...
Breaking Biology News(10 mins):Microplastic pollution discovered in St. Lawrence River sediments 2Scientists find how mysterious 'circular RNA' is formed, claim muscular dystrophy link 23rd annual Golden Goose award ceremony honors 8 researchers; Unusual work had big results 2
... that rising global temperatures accompanied by melting permafrost in ... into the atmosphere. Once released, that methane gas would ... radiation about 20 times more efficiently than does the ... appearing in the Journal of Geophysical Research ...
... that specially synthesized boron compounds are readily accepted in ... a proof of concept that could lead to new ... Oregon chemist Shih-Yuan Liu reported in the Journal ... of boron-nitrogen compounds with electronic and structural similarities to ...
... This release is available in German . ... restoration and maintenance of the Earth,s multi-trillion dollar ecosystems - ... can have a key role in countering climate change and ... of a new climate issues update by The Economics of ...
Cached Biology News:Methane gas likely spewing into the oceans through vents in sea floor 2Methane gas likely spewing into the oceans through vents in sea floor 3Boron-based compounds trick a biomedical protein 2Time to tap climate-change-combating potential of the world's ecosystems 2Time to tap climate-change-combating potential of the world's ecosystems 3Time to tap climate-change-combating potential of the world's ecosystems 4Time to tap climate-change-combating potential of the world's ecosystems 5