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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Interferon gamma-1b
Trade Name: Actimmune
Date Designated: 09/30/1996
Orphan Designation: Delaying time to disease progression in patients with severe, malignant osteopetrosis.
Orphan Designation Status: Designated/Approved
Horizon Therapeutic Ireland DAC
Connaught House, 1st Floor
1 Burlington Road
Dublin 4
Ireland

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

Marketing approved:

1 Generic Name: Interferon gamma-1b
Trade Name: Actimmune
Marketing Approval Date: 02/10/2000
Approved Labeled Indication: Delaying time to disease progression in patients with severe, malignant osteopetrosis.
Exclusivity End Date: 02/10/2007 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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