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:7/31/2014)... MOUNTAIN VIEW, Calif., July 31, 2014 IRIDEX Corporation ... the second quarter and six months ended June 28, 2014.  ... quarter of 2014, up 15% from $9.2 million in the ... the first quarter of 2014. Revenues for the first six ... million in the first six months of last year. ...
(Date:7/31/2014)... 31, 2014  Cepheid (NASDAQ: CPHD ) today ... conferences, and invited investors to participate via webcast. ... New York, NY Wednesday, August 13, 2014 at ... Conference, New York, NY Thursday, September ... Accessing Live Webcasts To access the live webcasts for these ...
(Date:7/31/2014)... 2014 Rock Creek Pharmaceuticals, Inc., (NASDAQ: ... the development of its lead molecule, Anatabine Citrate, in ... selected Quotient Clinical, The Translational Pharmaceutics Company, based in ... run its early development programs. The Company ... the end of the third quarter with the Medicines ...
Breaking Medicine Technology:IRIDEX Reports 2014 Second Quarter, Six-Month Results 2IRIDEX Reports 2014 Second Quarter, Six-Month Results 3IRIDEX Reports 2014 Second Quarter, Six-Month Results 4IRIDEX Reports 2014 Second Quarter, Six-Month Results 5IRIDEX Reports 2014 Second Quarter, Six-Month Results 6IRIDEX Reports 2014 Second Quarter, Six-Month Results 7Cepheid to Webcast Upcoming Financial Presentations 2Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs 2Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs 3Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs 4
(Date:8/2/2014)... When the Black Hat conventioneers descend on Las Vegas ... can be always counted on, plenty of FUD will be ... doubt. The run-up has already made its share of ... on July 31st about how hackers could use a ... infect a system with malware, completely undetected, by leveraging the ...
(Date:8/1/2014)... (PRWEB) August 01, 2014 Cannabis use among ... teens aged 14 to 17 having used marijuana at least ... With their slogan “Say ‘No’ to Drugs, Say ‘Yes to ... reaching out to youth this summer with factual information about ... past six months, Hamburg “Say ‘No’ to Drugs, Say ‘Yes’ ...
(Date:8/1/2014)... a central role in regulating appetite and whole-body metabolism. ... brain,s control of food intake and body weight, but ... been unclear. A new study in the ... activity in a type of neuron known as pro-opiomelanocortin ... high-fat diet. Sabrina Diano and colleagues at Yale ...
(Date:8/1/2014)... Aug. 1, 2014 (HealthDay News) -- The U.S. Food ... a new drug, Jardiance, to help fight type 2 ... or added to existing treatment regimens to control blood ... Curtis Rosebraugh, director of the Office of Drug Evaluation ... Research, said in an agency statement. The FDA ...
(Date:8/1/2014)... Summer is here, and with it comes ... summer, and they can be a pain for dogs. Animal ... all their customers get rid of ticks and prevent them ... in the summer, which is why they are so active ... and woodland areas and carry a number of diseases, including ...
Breaking Medicine News(10 mins):Health News:Black Hat USA 2014 Will Again Stress Need for Security Basics with Glimpse of What May Lie Ahead 2Health News:Black Hat USA 2014 Will Again Stress Need for Security Basics with Glimpse of What May Lie Ahead 3Health News:Black Hat USA 2014 Will Again Stress Need for Security Basics with Glimpse of What May Lie Ahead 4Health News:Black Hat USA 2014 Will Again Stress Need for Security Basics with Glimpse of What May Lie Ahead 5Health News:Addressing a Serious Issue Affecting German Teens 2Health News:FDA Approves New Type 2 Diabetes Drug 2Health News:Tis the Season for Tick Prevention 2
... University of New Hampshire finds that U.S. children are routinely ... previously recognized, with nearly half experiencing a physical assault in ... abuse and crime than do adults," said David Finkelhor, director ... study director. "If life were this dangerous for ordinary grown-ups, ...
... BANGKOK, Oct. 6 As thousands of experts around ... health and nutrition at the International Congress of Nutrition ... and Mars, Incorporated are acknowledging the important impact of ... Science - Flavanols and Sustainability," scientists will present evidence ...
... Los Angeles back surgeon, Dr. Rezaian of the California Orthopedic ... Spinal Stenosis . Open back surgery used to be ... pinching nerves, however, recent medical advances have given patients requiring ... of hope. Doctors have pioneered a new laser Spinal Stenosis ...
... ANGELES, Oct. 6 The Renaissance Laser and Vein Institute offers ... stretch marks and sagging skin like never before. Thanks to recent ... skin care lasers in the dermatological and cosmetic skin care world. ... is the Titan Procedure . The Titan laser ...
... Pelosi and the Democratic Women,s Working Group joined leaders from women,s ... discuss how women stand to gain the most ... face discrimination in both coverage and cost if health reform fails. ... , On Why Health Insurance Reform is Essential for ...
... D.D.S., who practices general dentistry in Flint, Mich., was inducted ... during a meeting of the ADA House of Delegates in ... presidency in October 2010 and will lead the more than ... Gist will be the ADA,s first African-American president. , Dr. ...
Cached Medicine News:Health News:New study finds high rates of childhood exposure to violence and abuse in US 2Health News:Cocoa Research Finds a Place in the Global Health Dialogue 2Health News:Cocoa Research Finds a Place in the Global Health Dialogue 3Health News:Cocoa Research Finds a Place in the Global Health Dialogue 4Health News:Cocoa Research Finds a Place in the Global Health Dialogue 5Health News:California Surgeon (laserbacksurgery.com) Pioneers Exciting Alternative to Traditional Spinal Stenosis Treatment 2Health News:Southern California Renaissance Laser and Vein Institute (laserandveinclinic.com) Offers Cutting Edge New Titan Procedure 2Health News:Pelosi: Health Insurance Reform Essential for Women 2Health News:Pelosi: Health Insurance Reform Essential for Women 3Health News:Pelosi: Health Insurance Reform Essential for Women 4Health News:Pelosi: Health Insurance Reform Essential for Women 5Health News:Michigan Dentist Chosen President-Elect of the American Dental Association 2
... Injection is supplied in an isotonic solution ... intravenous administration. Each milliliter contains 37 megabecquerels ... calibration time, made isotonic with 9 milligrams ... benzyl alcohol. The pH is adjusted to ...
... single-detector system offers general purpose ... for gurneys and wheelchairs. This ... versatile open gantry, caudal/cephalic detector ... for SPECT and whole body ...
Stainless steel lancet blade in stainless steel....
Sharp diamond shaped double blade in stainless steel....
Medicine Products: