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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N2'-Deacetyl-N2'-[4-methyl-4-(oxobuthyldithio)-1-oxopentyl]-maytansine-chimerized anti-CD138 IgG4 Monoclonal Antibody
Date Designated: 02/27/2008
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/06/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biotest AG
5 Landsteinerstraße
Dreieich, Hessen
Germany

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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