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Polivy
polatuzumab vedotin-piiq
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Polivy
Proper name
polatuzumab vedotin-piiq
Licence type
351(a)
BLA number
761121
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 140MG | For Injection | Intravenous | Single-Dose Vial | Rx | June 10, 2019 |
| 30MG | For Injection | Intravenous | Single-Dose Vial | Rx | September 18, 2020 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 19, 2030 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |