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Loargys
pegzilarginase-nbln
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Loargys
Proper name
pegzilarginase-nbln
Licence type
351(a)
BLA number
761211
Applicant
Immedica Pharma AB
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2MG/0.4ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | February 23, 2026 |
| 5MG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | February 23, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |