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Rystiggo
rozanolixizumab-noli
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Rystiggo
Proper name
rozanolixizumab-noli
Licence type
351(a)
BLA number
761286
Applicant
UCB, Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 280MG/2ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | June 26, 2023 |
| 420MG/3ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | June 14, 2024 |
| 560MG/4ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | June 14, 2024 |
| 840MG/6ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | June 14, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 26, 2030 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |