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Niktimvo
axatilimab-csfr
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Niktimvo
Proper name
axatilimab-csfr
Licence type
351(a)
BLA number
761411
Applicant
Incyte Corporation
Center
CDER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 22MG/0.44ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | January 14, 2025 |
| 22MG/2.2ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 24, 2026 |
| 50MG/ML | Injection | Intravenous | Single-Dose Vial | Disc | August 14, 2024 |
| 9MG/0.18ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | January 14, 2025 |
| 9MG/0.9ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 24, 2026 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 14, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |