Application 761161
- Type
- BLA
- Sponsor
- CHIESI FARMACEUTICI SPA
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761161 | Elfabrio | pegunigalsidase alfa-iwxj | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELFABRIO | PEGUNIGALSIDASE ALFA-IWXJ | VIAL; SINGLE-USE | 20MG/10ML | 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 |
|---|---|---|---|---|---|---|
| ELFABRIO | PEGUNIGALSIDASE ALFA | Chiesi USA, Inc. | 6fb674bf-744e-431f-92ef-b2a5a66c8cf3 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | BLA761161 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.