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Vabysmo
faricimab-svoa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Vabysmo
Proper name
faricimab-svoa
Licence type
351(a)
BLA number
761235
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 6MG/0.05ML (120MG/ML) | Injection | Intravitreal | Single-Dose Vial | Rx | January 28, 2022 |
| 6MG/0.05ML (120MG/ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | July 9, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |