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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: daratumumab
Date Designated: 08/06/2015
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/20/2021
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Janssen Research & Development, LLC
1400 McKean Road
P.O. Box 776
Spring House, Pennsylvania 19477
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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