Search Orphan Drug Designations and Approvals
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Generic Name: | Lepirudin | ||||||||||||||||
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Trade Name: | Refluden | ||||||||||||||||
Date Designated: | 02/13/1997 | ||||||||||||||||
Orphan Designation: | Treatment of heparin-associated thrombocytopenia type II. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Hoechst Marion Roussel Frankfurt am Main P.O. Box 1140 Marburg Germany The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Lepirudin |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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