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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: inebilizumab
Trade Name: Uplizna
Date Designated: 02/10/2016
Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders
Orphan Designation Status: Designated/Approved
Horizon Therapeutics Ireland DAC
70St. Stephen’s Green
Dublin 2 D02 E2X4
Ireland

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

Marketing approved:

1 Generic Name: inebilizumab
Trade Name: Uplizna
Marketing Approval Date: 06/11/2020
Approved Labeled Indication: Uplizna is indicated for for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Exclusivity End Date: 06/11/2027 
Exclusivity Protected Indication* :  Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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