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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Iboctadekin
Date Designated: 06/03/2005
Orphan Designation: Treatment of renal cell carcinoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/07/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GlaxoSmithKline LLC
Corporation service Company
Suite 400
Wilmington, Delaware 19808
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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