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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: NELATIMOTIDE AND ADEGRAMOTIDE combination
Date Designated: 06/19/2017
Orphan Designation: Treatment of myelodysplastic syndrome.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 06/23/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sumitomo Pharma Oncology, Inc.
84 Waterford Drive
Marlborough, Massachusetts 01752
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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