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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mogamulizumab
Trade Name: POTELIGEO
Date Designated: 11/02/2010
Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma.
Orphan Designation Status: Designated/Approved
Kyowa Kirin Pharmaceutical Development Inc.
212 Carnegie Center # 101
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: mogamulizumab
Trade Name: POTELIGEO
Marketing Approval Date: 08/08/2018
Approved Labeled Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
Exclusivity End Date: 08/08/2025 
Exclusivity Protected Indication* :  POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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