On this page
Bavencio
avelumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bavencio
Proper name
avelumab
Licence type
351(a)
BLA number
761049
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 23, 2017 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 23, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |