Navigation Links
Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
Date:8/8/2008

BRIDGEWATER, N.J., Aug. 8 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for Multaq(R) (dronedarone). The priority review period begins on July 31, 2008.

The priority review is granted to applications in which a new indication or new drug product, if approved, has the potential to present a safe and effective therapy where no satisfactory alternative exists compared to currently available therapies or marketed products.

A registration dossier is also under regulatory review by the European Medicines Agency (EMEA) for a Marketing Authorization Application.

"We are pleased that the FDA has designated Multaq(R) for priority review," said Marc Cluzel, sanofi-aventis Senior Vice President, R&D for sanofi-aventis. "This follows the exciting results of the landmark ATHENA study that showed Multaq(R) significantly decreased the risk of cardiovascular hospitalizations or death from any cause in patients with Atrial Fibrillation."

Atrial fibrillation is a major cause of hospitalization and mortality and affects about 2.5 million people in the United States, as well as 4.5 million people in the European Union and is emerging as a growing public health concern due to an aging population. Patients suffering from atrial fibrillation have twice the risk of death, an increased risk of stroke and cardiovascular complications, including congestive heart failure. Furthermore atrial fibrillation considerably impairs patients' lives, mainly because of their inability to perform normal daily activities due to complaints of palpitations, chest pain, dyspnoea, fatigue or light-headedness.

About Multaq(R) (dronedarone)

Dronedarone (brand name Multaq(R)) is an investigational new treatment for patients with atrial fibrillation, which has been discovered and developed by sanofi-aventis for t
'/>"/>

SOURCE sanofi-aventis
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fibrillation
2. ATHENA Clinical Results for Dronedarone (Multaq(R)) Highlighted at the World Cardiology Congress
3. ATHENA Clinical Results with Dronedarone (Multaq(R)) Highlighted at the World Cardiology Congress
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
6. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
7. Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
8. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
9. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
10. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
11. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... -- Shares of Aerie Pharmaceuticals, Inc. (NASDAQ: AERI ) ... results of the Phase 3 Rocket 1 trail of ... to meet its end points, compelling data from the ... studies. An analyst report on AERI that ... analyst summary, valuation, and recommendation can be viewed by ...
(Date:4/30/2015)... Omnicell, Inc. (NASDAQ: OMCL ), a leading provider of ... announced results for its first quarter ended March 31, ... quarter of 2015 was $116.2 million, up $14.5 million ... down $5.3 million or 4.4% from the fourth quarter ... as reported in accordance with U.S. generally accepted accounting ...
(Date:4/30/2015)... 30, 2015  Tandem Diabetes Care ® , Inc. (NASDAQ: ... the t:slim ® and t:flex™ Insulin Pumps, today reported ... In comparing the first quarter of 2015 ... 53 percent to $12.3 million from $8.1 million , ... 1,723 pumps "Our investment in resources to build ...
Breaking Medicine Technology:All is Not Lost for Aerie Pharmaceuticals - VLM Research Issued by BrokerBank Securities, Inc. 2Omnicell Announces First Quarter 2015 Results 2Omnicell Announces First Quarter 2015 Results 3Omnicell Announces First Quarter 2015 Results 4Omnicell Announces First Quarter 2015 Results 5Omnicell Announces First Quarter 2015 Results 6Omnicell Announces First Quarter 2015 Results 7Omnicell Announces First Quarter 2015 Results 8Omnicell Announces First Quarter 2015 Results 9Omnicell Announces First Quarter 2015 Results 10Omnicell Announces First Quarter 2015 Results 11Omnicell Announces First Quarter 2015 Results 12Omnicell Announces First Quarter 2015 Results 13Omnicell Announces First Quarter 2015 Results 14Omnicell Announces First Quarter 2015 Results 15Omnicell Announces First Quarter 2015 Results 16Omnicell Announces First Quarter 2015 Results 17Omnicell Announces First Quarter 2015 Results 18Omnicell Announces First Quarter 2015 Results 19Omnicell Announces First Quarter 2015 Results 20Omnicell Announces First Quarter 2015 Results 21Omnicell Announces First Quarter 2015 Results 22Omnicell Announces First Quarter 2015 Results 23Omnicell Announces First Quarter 2015 Results 24Omnicell Announces First Quarter 2015 Results 25Omnicell Announces First Quarter 2015 Results 26Omnicell Announces First Quarter 2015 Results 27Tandem Diabetes Care Reports First Quarter 2015 Financial Results 2Tandem Diabetes Care Reports First Quarter 2015 Financial Results 3Tandem Diabetes Care Reports First Quarter 2015 Financial Results 4Tandem Diabetes Care Reports First Quarter 2015 Financial Results 5Tandem Diabetes Care Reports First Quarter 2015 Financial Results 6
... A new study published online today ... NEJM) shows bevacizumab (Avastin) is as effective as ranibizumab ... treating age-related macular degeneration (AMD). The ... Trials" (CATT) study, a pioneering comparative effectiveness trial made ...
... 2011 PharmaNet Development Group, Inc., a leading provider ... and medical device companies, announced today that Valerie Palumbo ... Quality Assurance. "We are very pleased ... President, PharmaNet Development Group. "Valerie brings deep experience in ...
Cached Medicine Technology:Cleveland Clinic-Led Study Finds Bevacizumab as Effective as FDA-Approved Ranibizumab in Treating Macular Degeneration 2Cleveland Clinic-Led Study Finds Bevacizumab as Effective as FDA-Approved Ranibizumab in Treating Macular Degeneration 3Cleveland Clinic-Led Study Finds Bevacizumab as Effective as FDA-Approved Ranibizumab in Treating Macular Degeneration 4
(Date:5/3/2015)... SpineFrontier, a Less Exposure Surgery (LES) technology company, ... market their new sacroiliac joint fusion screw, the SIJ ... and is compatible with both lateral and alternate posterior ... researched and refined by SpineFrontier, the first company to ... conjunction with a sacroiliac joint fusion system like this. ...
(Date:5/2/2015)... As one of only 30 Illinois companies to ... Achievement and Recognition Program (SHARP) certification, Essentra Specialty ... Illinois Department of Labor to host this special event. ... by the Occupational Safety and Health Administration’s (“OSHA”) Onsite ... meet or exceed all of the necessary regulations and ...
(Date:5/2/2015)... “ ActOn ” was featured on NewsWatch ... at the latest and coolest applications on the market for ... and technology expert, conducted the app review and shared with ... organizations to make a difference. , In this material world, ... that aren’t about money, which is why those things should ...
(Date:5/2/2015)... We are pleased to announce the Sun ... one of the Top Workplaces of 2015. , The ... field for their ethics and standards of excellence. The ... their educational efforts. The Delray Recovery Center prides itself ... purpose – to help individuals heal from the disease ...
(Date:5/2/2015)... May 02, 2015 Kare Visits LLC. launched ... for busy caregivers. Kare Visits offers relief for caregivers ... living facilities. According to the Caregiver Action Network, ... average of 20 hours a week caring for an elderly ... cost to hire a nurse, a caregiver is now empowered ...
Breaking Medicine News(10 mins):Health News:Essentra Specialty Tapes is Selected to Host Gov. Rauner and the Workers' Memorial Day Celebration 2Health News:Essentra Specialty Tapes is Selected to Host Gov. Rauner and the Workers' Memorial Day Celebration 3Health News:An Application to Help People Make a Difference Was Featured on NewsWatch Television 2Health News:The Delray Recovery Center Named 2015 Top Workplace 2Health News:Chicagoan Seeks to Transform Industry by Launching an Innovative Elderly Care Solution 2
... Britain’s biggest supermarket, TESCO, was in public glare for the wrong ... of land and for not being party to a movement that ... Standards Agency got after Tesco, soon after the latter rejected the ... has made profits of over ?2 billion last year and a ...
... in the 'Pongala Mahotsavam,' festival at the Attukal Bhagavathy temple, ... began on March 5 and will culminate as a grand ... a very auspicious and important festival of this temple, which ... The devotees make a dish of rice and jaggery as ...
... decided to provide health insurance to approximately 80,000 employers ... funding for the insurance would be contributed by the ... ,Mike Huckabee of the Arkansas Government has ... employees. This move is anticipated to yield considerable revenue ...
... resentment against the NHS proposal to allow nurses to ... the move as being equivalent to entrusting airhostesses // ... the British Medical Association (BMA) has been urged to ... to conduct operations on patients. More than 130 doctors ...
... China have identified the deadly H5N1 virus in geese, ducks ... sparking fears of bird flu pandemic//. ,It has ... flu virus. This however is the first time that large-scale ... chickens. Infected chickens usually die within 24 hours of the ...
... West Bengal Chief Minister Buddhadeb Bhattacharya has pledged to ... ,The general secretary of Ganadarpan, Brojo Roy said ... in this cause." Ganadarpan is an NGO with which ... ,Bhattacharya joins other communist leaders like Jyoti Basu, Somnath ...
Cached Medicine News:Health News:Doctors Protest Against Allowing Nurses To Perform Minor Surgeries 2Health News:Healthy, Bird Flu Infected Chickens In Chinese Markets 2
... Knife with BD Xstar Blade includes a ... the blade in prodedure and handling. ... a grind-less process for manufacturing surgical blades. ... and consistency. The arch style, single-bevel ...
Consists of the print and PDA versions of Harrison's Manual of Medicine 15th Edition. Provides high-end medical content via PDA....
Product includes all 15 Lexi-Comps databases. Includes Lexi-drugs, the official reference of the American Pharmacists Association and the National Professional Society of Pharmacists....
... The SphygmoCor Mx Central Blood ... of the SphygmoCor Px system by ... aortic pressure waveform., ,Key cardiovascular parameters ... trended. These parameters include:, Central ...
Medicine Products: