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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 and hyaluronidase-fihj
Trade Name: Darzalex Faspro
Date Designated: 10/06/2020
Orphan Designation: treatment of light-chain (AL) amyloidosis
Orphan Designation Status: Designated/Approved
Janssen Research & Development, LLC
1400 McKean Road
PO Box 776
Spring House, Pennsylvania 19477
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: daratumumab and hyaluronidase-fihj
Trade Name: Darzalex Faspro
Marketing Approval Date: 01/15/2021
Approved Labeled Indication: in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis
Exclusivity End Date: 01/15/2028 
Exclusivity Protected Indication* :  treatment of adult patients with newly diagnosed light chain (AL) amyloidosis
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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