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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  satralizumab-mwge
Trade Name:  ENSPRYNG™
Date Designated:  06/30/2014
Orphan Designation:  Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/14/2020 
Approved Labeled Indication:  treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
Exclusivity End Date:    08/14/2027 
Exclusivity Protected Indication* :  treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
GENENTECH, INC.
1 DNA WAY
SOUTH SAN FRANCISCO, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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