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FDA has approved Boehringer Ingelheim's oral direct thrombin inhibitor Pradaxa® (dabigatran etexilate) for use in reducing the risk of stroke in patients [...]

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ROCKVILLE, Md -- October 20, 2010 -- The US Food and Drug Administration (FDA) has approved dabigatran etexilate capsules (Pradaxa) for the prevention of [...]

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WEDNESDAY, Oct. 20 (HealthDay News) -- Pradaxa (dabigatran etexilate) has been approved by the US Food and Drug Administration to help prevent stroke in [...]

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Meanwhile, in a far less flashy decision, an FDA advisory panel voted unanimously to recommend approval of the investigational anticoagulant dabigatran to [...]

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Earlier this week, Boehringer Ingelheim's anticoagulant Pradaxa (dabigatran etexilate) won the unanimous assent of an FDA advisory committee for stroke [...]

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Silver Spring, MD - Late Tuesday, the US FDA announced it has approved dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke and systemic [...]

30 Mar 2010 Dabigatran etexilate is recommended as a possible treatment to reduce the risk of venous thromboembolism in adults who have surgery to [...]

Find out about the science and chemistry of Dabigatran (Pradaxa, anticoagulant), see colourful images of Dabigatran and explore interactive 3D molecules of [...]

21 Sep 2010 The FDA's Cardiovascular and Renal Drugs Advisory Committee has voted 9-0 for approval of the investigational anticoagulant dabigatran, [...]

21 Sep 2010 The FDA's Cardiovascular and Renal Drugs Advisory Committee has voted 9-0 for approval of the investigational anticoagulant dabigatran, [...]

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The FDA has announced that dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in atrial fibrillation will be the subject of a Cardiovascular and Renal Drugs ADvisory Committee on September 20. [...]

/PRNewswire/ -- Boehringer Ingelheim today announced results from a pre-specified, retrospective, un-blinded sub-analysis of the RE-LY® trial – the largest atrial fibrillation outcomes trial ever conducted(2) – were published in The [...]

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The concomitant use of PRADAXA with P-gp inducers (eg, rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, [...]

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention o [...]

Sub-analysis shows no significant interaction between trial centers' time in therapeutic range and stroke with either dose of dabigatran etexilate compared to warfarin(1). read more. [...]

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It affects millions, and is increasingly expensive to treat. AF's primary complication is stroke. Warfarin is the present standard of care, but I understand dabigatran is an exciting new drug used to prevent strokes in patients with AF. [...]

A dose-finding study saw what were characterized as low bleeding rates associated with triple-drug antithrombotic therapy that included the oral anticoagulant dabigatran in patients with a recent ACS event and other cardiovascular risk [...]

Boehringer Ingelheim has filed an application in Japan for the approval of the direct thrombin inhibitor Pradaxa (dabigatran etexilate) for the prevention of stroke in atrial fibrillation (AF) patients. The Japanese subsidiary of the [...]

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There is a lot of big news coming out of the European Society of Cardiology (ESC) going on in Barcelona right now. Judging by attendance, this is probably the biggest cardiology event in the world. The big announcement. [...]

Dabigatran Approved for Stroke Prevention in Atrial Fibrillation The FDA has approved the oral anticoagulant dabigatran (Pradaxa) to prevent stroke and blood clots in patients with atrial fibrillation. Approval follows the RE-LY trial, in which dabigatran was noninferior to warfarin in terms of a co [...]

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The US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee today voted 9 to 0 in favor of approving dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AFib). [...]

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From Medscape:Barring any unforeseen damning revelations about the drug, the FDA's approval of the oral thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim) for stroke prevention in atrial fibrillation (AF) is all but certain. [...]

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The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). [...]

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The US Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate), Boehringer Ingelheim's novel, oral direct thrombin inhibitor for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) marking the first approval of a new oral anticoagulant in the U.S. in more than 50 years. [...]