Navigation Links
FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
Date:10/19/2010

RIDGEFIELD, Conn., Oct. 19 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate) capsules to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).(1)  PRADAXA, an oral direct thrombin inhibitor(2) that was discovered and developed by Boehringer Ingelheim, is the first new oral anticoagulant approved in the U.S. in more than 50 years.  As demonstrated in the RE-LY® trial, PRADAXA 150mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin,(1) the current standard of care for patients with non-valvular atrial fibrillation. PRADAXA 150mg taken twice daily significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.(1)  

The FDA approval of PRADAXA(1) provides a new treatment to reduce the risk of stroke for the increasing number of patients with AFib.(3)  The safety and efficacy profile of PRADAXA was established based on the results of the 18,113 patient RE-LY® trial, the largest stroke prevention trial in AFib patients completed to date.(4) Treatment with PRADAXA does not require blood monitoring or related dose adjustments and has no recommended dietary restrictions.(1)  The FDA also approved PRADAXA 75mg twice daily for the small subset of patients who have severe renal impairment.(1)  

"For many years, physicians have been searching for new options to reduce the risk of stroke faced by millions of patients with atrial fibrillation. Many of these patients are either not receiving anticoagulation therapy or are taking it sub-optimally, placing them at risk for stroke or major bleeding," explained Jonathan L. Halperin, M.D., Director of Clinical Cardiology Services, Mount Sinai Medical Center.  "Pradaxa represents an exciting new treatment option for patients with non-valvular atrial
'/>"/>

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... MultiCell Technologies, Inc. (OTC Bulletin Board: MCET.OB ... composition of matter, biological targets, mechanism of action, methods ... This patent application describes a novel class ... which interfere with the basic homeostatic cellular processes in ...
(Date:1/15/2014)... GENEVA, Ill. , Jan. 15, 2014 The ... a Medical Fitness Center by the Medical Fitness Association, ... centers to achieve their full potential. The Cadence Fitness ... in the western suburbs and second in the Chicagoland ...
(Date:1/15/2014)... , Jan. 15, 2014 Reportlinker.com ... is available in its catalogue: ... – Worldwide Analysis http://www.reportlinker.com/p01957812/Insulin-Pump-Market--Forecast-–-Worldwide-Analysis.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Equipment_and_Supply ... Analysis Insulin Pumps ...
Breaking Medicine Technology:MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Insulin Pump Market & Forecast - Worldwide Analysis 2Insulin Pump Market & Forecast - Worldwide Analysis 3Insulin Pump Market & Forecast - Worldwide Analysis 4Insulin Pump Market & Forecast - Worldwide Analysis 5Insulin Pump Market & Forecast - Worldwide Analysis 6Insulin Pump Market & Forecast - Worldwide Analysis 7Insulin Pump Market & Forecast - Worldwide Analysis 8Insulin Pump Market & Forecast - Worldwide Analysis 9Insulin Pump Market & Forecast - Worldwide Analysis 10Insulin Pump Market & Forecast - Worldwide Analysis 11Insulin Pump Market & Forecast - Worldwide Analysis 12Insulin Pump Market & Forecast - Worldwide Analysis 13Insulin Pump Market & Forecast - Worldwide Analysis 14Insulin Pump Market & Forecast - Worldwide Analysis 15Insulin Pump Market & Forecast - Worldwide Analysis 16Insulin Pump Market & Forecast - Worldwide Analysis 17
(Date:4/17/2014)... chronic inflammation in non-cancerous prostate tissue may have nearly ... those with no inflammation, according to results of a ... Kimmel Cancer Center. , The link between persistent inflammation ... high-grade prostate cancer those with a Gleason score ... the most aggressive and rapidly growing prostate cancers. , ...
(Date:4/17/2014)... vaccine brands for children may not be the most ... factors when choosing vaccines, driving the market toward what ... new study by University of Illinois researchers. , "The ... numerous factors," says Sheldon H. Jacobson, a co-author of ... of mathematics at the U. of I. "In an ...
(Date:4/17/2014)... at the University of California, San Diego School of ... who have suffered a recent major loss are more ... adults. , The study is published in this month,s ... . , Because compassionate behaviors are associated with better ... offer insights into ways to improve the outcomes of ...
(Date:4/17/2014)... Hospital Pediatrician-in-Chief Jon McCullers, MD, was recently invited ... of Nature Reviews Microbiology , one of ... a world-renowned infectious disease specialist, and chair of ... Tennessee Health Science Center, analyzed the epidemiology and ... 1968 pandemics, as well as more recent 2009 ...
(Date:4/17/2014)... MAYWOOD, Il. (April 17, 2014) Doctors who ... disease called lymphangioleiomyomatosis (LAM) can face an agonizing ... progression of the disease and help relieve shortness ... lung transplants, and sirolimus can cause potentially fatal ... said pulmonologist Dr. Daniel Dilling, medical director of ...
Breaking Medicine News(10 mins):Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Study recalculates costs of combination vaccines 2Health News:The ilk of human kindness 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3
... the Journal of the American Geriatrics Society says that the dying ... // The study found that Arab Americans did not want to ... did not mind it. Hispanic people want to die with dignity ... ,White people did not want to be taken care of by ...
... by non veg items but now roam tomatoes have been found ... three outbreaks in 2004 were caused by this agent. ,The ... havoc. ,The link was establoished when it was ... that was roma tomatoes. ,So the direct culprit was ...
... H. Purcell, NIAID's Laboratory of Infectious Diseases, and Bernard Moss, ... which is found to prevent and treat small pox virus ... there is an increased fear over the use of small ... ,Small pox referral strains are only available in ...
... Professor Michael Beckmann and his colleagues have reported in ... to the lower genital tract reduces// the surgical procedure ... ,Episiotomy is a surgical procedure done in the perineum ... the labor period involved during birthing process to expand ...
... of anxiety-ridden fathers are passed on to the mothers ... many as 65 women were studied by the University ... this conclusion. ,This increased the pain women ... their immediate recovery and factors such as breastfeeding and ...
... dementia at a latter age can be halved as a ... published in the Psychological Medicine//. Cognitive decline can be prevented ... As many as 29,000 people from 22 studies conducted across ... Dr Michael Valenzuela has revealed that where the brain is ...
Cached Medicine News:Health News:Death Wishes Influenced By Ethnicity and Racial Background 2
The ultra micro tip for the new Eppendorf 2000/2100 series ultra micro pipettors provides accurate drawing and dispensing everytime....
... available as both regular and filter tips. ... for more efficient sterilization and are delivered ... date of irradiation. Sterilized Diamond Tips are ... SterilPack Diamond Tips are wrapped in medical ...
This ultra micro tip for the Eppendorf and Nichiryo/BenchMate 0.5-10 L pipettors is perfect for working with low volume....
1000 L, Bulk Recommended for 500 and 1000 L pipettes....
Medicine Products: