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Piasky
crovalimab-akkz
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Piasky
Proper name
crovalimab-akkz
Licence type
351(a)
BLA number
761388
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 340MG/2ML (170MG/ML) | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | June 20, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 20, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |