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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: idarucizumab
Trade Name:
Date Designated: 05/28/2015
Orphan Designation: To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure
Orphan Designation Status: Designated/Approved
Boehringer Ingelheim Pharmaceuticals, Inc.
PO Box 368
900 Ridgebury Road
Ridgefield, Connecticut 06877
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: idarucizumab
Trade Name:
Marketing Approval Date: 10/16/2015
Approved Labeled Indication: For use in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding
Exclusivity End Date: 10/16/2022 
Exclusivity Protected Indication* :  For use in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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