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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: coagulation factor VIIa (recombinant)
Trade Name: NovoSeven RT
Date Designated: 06/18/2004
Orphan Designation: Treatment of bleeding episodes in Glanzmann's thrombasthenia
Orphan Designation Status: Designated/Approved
Novo Nordisk Inc.
800 Scudders Mill Rd.
Plainsboro, New Jersey 08536
United States

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

Marketing approved:

1 Generic Name: coagulation factor VIIa (recombinant)
Trade Name: NovoSeven RT
Marketing Approval Date: 07/02/2014
Approved Labeled Indication: Treatment of bleeding episodes and peri-operative management in adults and children with Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.
Exclusivity End Date: 07/02/2021 
Exclusivity Protected Indication* :  Treatment of bleeding episodes and peri-operative management in adults and children with Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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