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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: antihemophilic factor (recombinant), porcine sequence
Trade Name: OBIZUR
Date Designated: 03/16/2004
Orphan Designation: Treatment and prevention of episodic bleeding in patients with inhibitor antibodies to human coagulation factor VIII
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: antihemophilic factor (recombinant), porcine sequence
Trade Name: OBIZUR
Marketing Approval Date: 10/23/2014
Approved Labeled Indication: Treatment of bleeding episodes in adults with acquired hemophilia A.
Exclusivity End Date: 10/23/2021 
Exclusivity Protected Indication* :  Treatment of bleeding episodes in adults with acquired hemophilia A.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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