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FDA Grants Breakthrough Therapy Designation To Pradaxa® (Dabigatran Etexilate) Specific Investigational Antidote



6/30/2014 10:51:52 AM

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INGELHEIM, Germany--(BUSINESS WIRE)--For media outside of the U.S., the UK & Canada only

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational antidote idarucizumab* (a humanized antibody fragment), currently being studied as a specific antidote for the oral anticoagulant Pradaxa® (dabigatran etexilate).3

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