On this page
Enspryng
satralizumab-mwge
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Enspryng
Proper name
satralizumab-mwge
Licence type
351(a)
BLA number
761149
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 120MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 14, 2020 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 14, 2027 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |