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Lunsumio Velo
mosunetuzumab-axgb
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lunsumio Velo
Proper name
mosunetuzumab-axgb
Licence type
351(a)
BLA number
761263
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 45MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | December 19, 2025 |
| 5MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | December 19, 2025 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 22, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |