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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Lepirudin
Trade Name: Refluden
Date Designated: 02/13/1997
Orphan Designation: Treatment of heparin-associated thrombocytopenia type II.
Orphan Designation Status: Designated/Approved
Hoechst Marion Roussel
Frankfurt am Main
P.O. Box 1140

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

Marketing approved:

1 Generic Name: Lepirudin
Trade Name: Refluden
Marketing Approval Date: 03/06/1998
Approved Labeled Indication: For anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further thromboembolic complications.
Exclusivity End Date: 03/06/2005 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.