April 24, 2017

FDA gets request to approve Pradaxa reversal agent idarucizumab

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 Ingelheim submits applications for approval of idarucizumab*, specific reversal agent to dabigatran etexilate (Pradaxa®), to EMA, FDA and Health Canada

 

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  1. 3. I read your blog post about how the FDA got a request to approve Pradaxa reversal agent Idarucizumad. Boehringer Ingelheim submitted an application to the FDA requesting the approval of the drug. In addition they submitted for marketing approval Health Canada the European Medicines Agency (EMA).

  2. I read your blog post about how the FDA got a request to approve Prodaxa reversal agent Idarucizumad. Boehringer Ingelheim submitted an application to the FDA requesting the approval of the drug. In addition they submitted for marketing approval Health Canada the European Medicines Agency (EMA).

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