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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: melphalan
Trade Name: EVOMELA
Date Designated: 11/24/2008
Orphan Designation: High dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation
Orphan Designation Status: Designated/Approved
Acrotech Biopharma LLC
279 Princeton Hightstown Road
East Windsor, New Jersey 08520
United States

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

Marketing approved:

1 Generic Name: melphalan
Trade Name: EVOMELA
Marketing Approval Date: 03/10/2016
Approved Labeled Indication: for high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma
Exclusivity End Date: 03/10/2023 
Exclusivity Protected Indication* :  for high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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