Application 125460
- Type
- BLA
- Sponsor
- BIOMARIN PHARM
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125460 | Vimizim | elosulfase alfa | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIMIZIM | ELOSULFASE ALFA | INJECTABLE;INJECTION | 5MG/5ML | 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 |
|---|---|---|---|---|---|---|
| VIMIZIM | ELOSULFASE ALFA | BioMarin Pharmaceutical Inc. | 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | BLA125460 68135-100 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68135-100 | VIMIZIM | elosulfase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-100 | VIMIZIM | elosulfase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-100 | VIMIZIM | elosulfase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-100 | VIMIZIM | elosulfase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-100 | VIMIZIM | elosulfase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-100 | VIMIZIM | elosulfase alfa | BioMarin Pharmaceutical Inc. | BLA | Current |