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

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:12/19/2014)... Thompson HealthDay Reporter ... into the United States -- along with Angelina Jolie,s ... have highlighted cracks in the nation,s public health defense ... report released Thursday. Half of U.S. states are ... disease outbreaks. That was the main conclusion of the ...
(Date:12/19/2014)... The global magnetic resonance imaging (MRI) ... is saturated with numerous players developing innovative technologies. ... as non-invasive nature, MRI systems have seen continued ... healthcare market. Rapid advances in the field imaging ... have greatly expanded the potential of therapeutic applications. ...
(Date:12/19/2014)... 2014 Pain Free Living a leader ... announce a new Superior magnetic necklace using ... the strongest neodymium magnets for the fastest pain relief ... the Superior Magnetics brand for the fastest relief by ... magnetic therapy using Superior Magnetic Jewelry at fairs and ...
(Date:12/19/2014)... Slone Partners , a ... healthcare information technology, and laboratory testing industries, has ... Operating Officer. The announcement comes after a year ... strengthened presence in Boston and several new additions ... breathes the client experience," said Adam Slone, Chief ...
(Date:12/19/2014)... Consilium Staffing, Your Partner in ... for Federal Health Professionals annual meeting in Washington, ... military and federal healthcare providers. , In ... Business Engagement (NVSBE) conference last week in Atlanta, ... vital solution in addressing our nation’s shortage of ...
Breaking Medicine News(10 mins):Health News:Most States Not Ready to Handle Infectious Disease Outbreaks: Report 2Health News:Most States Not Ready to Handle Infectious Disease Outbreaks: Report 3Health News:Most States Not Ready to Handle Infectious Disease Outbreaks: Report 4Health News:Magnetic Resonance Imaging Systems Market Analysis and Forecast to 2020 Report at RnRMarketReserach.com 2Health News:Magnetic Resonance Imaging Systems Market Analysis and Forecast to 2020 Report at RnRMarketReserach.com 3Health News:Magnetic Resonance Imaging Systems Market Analysis and Forecast to 2020 Report at RnRMarketReserach.com 4Health News:New Superior Magnetic Necklace Relieves Migraine Headache 2Health News:Slone Partners Promotes Leslie Loveless to Chief Operating Officer 2Health News:Consilium Staffing Increasing Awareness of Locum Tenens through Conference Appearances 2
... heart patients make use of all 36 Medicare-funded sessions, researchers ... rehabilitation sessions for elderly people with heart disease can lower ... new research finds, but fewer than one in five eligible ... of more than 30,000 Medicare patients aged 65 and older ...
... , WASHINGTON, Dec. 21 ... for passage of the amended Senate health system reform bill ... Care Act by the Senate will bring our nation close ... (Logo: http://www.newscom.com/cgi-bin/prnh/20081209/AMALOGO ) , "All Americans deserve affordable, ...
... , ... tradition of charitable giving at Projects In Knowledge ( www.projectsinknowledge.com ... holiday season. Over the last few months, the company has ... global organizations, all aimed at providing seasonal cheer and assistance ...
... , AVENTURA, Fla., Dec. 21 Cinergy Health ... for the consumer market, expressed its concern for the ongoing healthcare ... , "While the Senate and House healthcare bills are far from ... expanding access to affordable health coverage for all Americans," said ...
... cars shrinks and reaction times grow, study finds , MONDAY, ... themselves and others in danger as they switch their attention ... Researchers who placed young adults in a virtual driving simulator ... car ahead shrank when texting came into the mix, but ...
... to ensure protection, experts say, , MONDAY, Dec. 21 ... flu vaccine may be enough to guard children and ... the U.S. Centers for Disease Control and Prevention recommends ... H1N1 vaccine, spaced about a month apart. This is ...
Cached Medicine News:Health News:With Cardiac Rehab, More Is Better: Study 2Health News:AMA Announces Support for Passage of Senate Health Reform Bill 2Health News:AMA Announces Support for Passage of Senate Health Reform Bill 3Health News:Projects In Knowledge(R) Is Brightening the Holidays for Many in Need 2Health News:Projects In Knowledge(R) Is Brightening the Holidays for Many in Need 3Health News:Projects In Knowledge(R) Is Brightening the Holidays for Many in Need 4Health News:Cinergy Health Commentary on Senate Healthcare Vote 2Health News:Texting While Driving Raises Crash Risk Sixfold 2Health News:Single Shot of H1N1 Vaccine May Be Enough for Kids 2Health News:Single Shot of H1N1 Vaccine May Be Enough for Kids 3
(Date:12/17/2014)...  RXi Pharmaceuticals Corporation (NASDAQ: RXII ... and commercializing innovative therapies addressing major unmet medical ... in its first Phase 2a study, RXI-109-1301.  The ... 1-month findings that were reported in September of ... http://photos.prnewswire.com/prnh/20130917/NE80755LOGO , , , ...
(Date:12/15/2014)... and Markets ( http://www.researchandmarkets.com/research/bf3b6l/electrocardiogram ) has announced ... Global Trends, Estimates and Forecasts, 2012-2018" report to ... Global Electrocardiogram Devices (ECG) sector is projected ... North America accounts for nearly 36% (2015) ... claims approximately 27% (2018). Asia-Pacific ...
(Date:12/15/2014)... PLYMOUTH MEETING, Pa. , Dec. 15, 2014 ... ) announced today it has been added to ... the NASDAQ Biotechnology Index will become effective upon ... The NASDAQ Biotechnology Index is designed to track ... that are classified as either biotechnology or pharmaceutical ...
Breaking Medicine Technology:RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 2Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 3Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 4Inovio Pharmaceuticals Added to NASDAQ Biotechnology Index 2Inovio Pharmaceuticals Added to NASDAQ Biotechnology Index 3Inovio Pharmaceuticals Added to NASDAQ Biotechnology Index 4
... Amgen Inc. (Nasdaq: AMGN ),today released ... of,the long-term safety and efficacy of Nplate(TM) (romiplostim) ... Chronic ITP is a,chronic and serious autoimmune disorder ... blood, sometimes leading to serious bleeding events.,The results ...
... BEACH, California and AMSTERDAM, December 8 ,Agendia, a ... that,leading Agendia and the Netherlands Cancer Institute researchers ... San Antonio Breast Cancer Symposium,(SABCS) and Agendia will ... Individualized Breast Cancer Therapy symposium. The San Antonio,Breast ...
Cached Medicine Technology:Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 2Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 3Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 4Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 5Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 6Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 7Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 8Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 9Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 10Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 11Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients 12Agendia Supports High Profile CME Symposium and Presents Compelling Data at the 2008 San Antonio Breast Cancer Symposium 2Agendia Supports High Profile CME Symposium and Presents Compelling Data at the 2008 San Antonio Breast Cancer Symposium 3Agendia Supports High Profile CME Symposium and Presents Compelling Data at the 2008 San Antonio Breast Cancer Symposium 4
Designed for rapid, routine electrophoresis for nucleic acids. The Mini unit is designed with a choice of two casting systems: standard casting trays that require sealing tape; or aluminum-gated cast...
... to set up and safe to use, the ... casting and running agarose gels. The unit is ... The direct-connect power supply eliminates a tangled mess ... saves space. Designed for safety and convenience, the ...
... horizontal gel system is designed for very fast and ... This System allows the user to cast, run, and ... system with : 1 x electrophoresis tank and cover, ... x 83 mm tray), 2 x MT-T02 (50 x ...
... Submarine Unit for nucleic acid analysis in the mini ... fast separations of DNA restriction fragments in agarose gels. ... the base with coolant and seal. Precool the unit ... in a freezer or by immersing it in an ...
Medicine Products: