Search Orphan Drug Designations and Approvals
-
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 | ||||||||||||||||
Sponsor: |
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. |
||||||||||||||||
Marketing approved: |
|||||||||||||||||
1 | Generic Name: | satralizumab-mwge |
---|---|---|
Trade Name: | Enspryng | |
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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-