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Spevigo
spesolimab-sbzo
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Spevigo
Proper name
spesolimab-sbzo
Licence type
351(a)
BLA number
761244
Applicant
LEO Pharma A/S
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | March 18, 2024 |
| 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 28, 2025 |
| 450MG/7.5ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | September 1, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 18, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |