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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: astuprotimut-R
Date Designated: 05/29/2009
Orphan Designation: Treatment of MAGE-A3 positive stages IIb to IV malignant melanoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 10/09/2015
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GlaxoSmithKline Biologicals, S.A.
Rue de l'Institut 89
B-1330 Rixensart
Belgium

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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