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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Tagraxofusp-erzs
Trade Name: ELZONRIS
Date Designated: 06/06/2013
Orphan Designation: Treatment of blastic plasmacytoid dendritic cell neoplasm
Orphan Designation Status: Designated/Approved
Stemline Therapeutics, Inc.
750 Lexington Avenue
11th floor
New York, New York 10022
United States

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

Marketing approved:

1 Generic Name: Tagraxofusp-erzs
Trade Name: ELZONRIS
Marketing Approval Date: 12/21/2018
Approved Labeled Indication: ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
Exclusivity End Date: 12/21/2025 
Exclusivity Protected Indication* :  ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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