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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)
Trade Name: ReFacto, Xyntha
Date Designated: 02/08/1996
Orphan Designation: For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
Orphan Designation Status: Designated/Approved
Wyeth Pharmaceuticals, Inc.
P. O. Box 8299
Philadelphia, Pennsylvania 19101
United States

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

Marketing approved:

1 Generic Name: Antihemophilic factor (recombinant)
Trade Name: ReFacto, Xyntha
Marketing Approval Date: 03/06/2000
Approved Labeled Indication:
Exclusivity End Date: N/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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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