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Bimzelx
bimekizumab-bkzx
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bimzelx
Proper name
bimekizumab-bkzx
Licence type
351(a)
BLA number
761151
Applicant
UCB, Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 160MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | October 17, 2023 |
| 160MG/ML | Injection | Subcutaneous | Autoinjector | Rx | October 17, 2023 |
| 320MG/2ML (160MG/2ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | October 11, 2024 |
| 320MG/2ML (160MG/2ML) | Injection | Subcutaneous | Autoinjector | Rx | October 11, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |