Application 761211
- Type
- BLA
- Sponsor
- IMMEDICA PHARMA AB
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761211 | Loargys | pegzilarginase-nbln | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOARGYS | PEGZILARGINASE-NBLN | Injectable; Injection | 0.1MG/KG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loargys | PEGZILARGINASE-NBLN | Immedica Pharma US Inc. | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | BLA761211 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.