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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ustekinumab; human monocloncal antibody to interkeukin 12p40
Date Designated: 12/22/2011
Orphan Designation: Treatment of primary biliary cirrhosis
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Janssen Biotech, Inc.
200 Great Valley Parkway
Malvern, Pennsylvania 19355
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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