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Pradaxa (dabigatran) approved as alternative to warfarin for reducing atrial fibrillation stroke risk

The long-awaited alternative to Coumadin (warfarin) has just been approved by the US FDA. The FDA just approved Pradaxa (dabigatran) for use by those with atrial fibrillation for preventing afib-related strokes. The FDA based approval on results of the RE-LY trial, which saw patients on Pradaxa having fewer strokes than those on warfarin. And Pradaxa …

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Breaking News: FDA Panel Unanimously Recommends Approval of Dabigatran to Decrease Stroke Risk in Atrial Fibrillation

An FDA panel today unanimously recommended that the FDA approve dabigatran (Pradaxa) for reducing the risk of afib strokes. FDA approval is expected quickly, making this the first alternative to warfarin approved in the United States, and also the first atrial fibrillation approval for dabigatran. It is approved in over 70 countries for venous thromboembolisms …

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