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Vyvgart
efgartigimod alfa-fcab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Vyvgart
Proper name
efgartigimod alfa-fcab
Licence type
351(a)
BLA number
761195
Applicant
Argenx BV
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | December 17, 2021 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 17, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |