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FDA gets request to approve Pradaxa reversal agent idarucizumab

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Big news! Boehringer Ingelheim has submitted an application to the FDA requesting accelerated approval for idarucizumab, the reversal agent for Pradaxa (dabigatran). See: Boehringer Ingelheim Submits Biologics License Application to FDA for Idarucizumab*, Investigational Specific Reversal Agent for Pradaxa® Additionally, they have submitted for marketing approval by Health Canada and the European Medicines Agency (EMA). See: Boehringer …

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