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Skyrizi
risankizumab-rzaa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Skyrizi
Proper name
risankizumab-rzaa
Licence type
351(a)
BLA number
761105
Applicant
AbbVie Inc.
Center
CDER
Presentations
9
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 26, 2021 |
| 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | April 26, 2021 |
| 180MG/1.2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | September 23, 2022 |
| 180MG/1.2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | September 3, 2025 |
| 360MG/2.4ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | June 16, 2022 |
| 55MG/0.37ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 12, 2026 |
| 600MG/10ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 16, 2022 |
| 75MG/0.83ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | April 23, 2019 |
| 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | March 22, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |