Application 761434
- Type
- BLA
- Sponsor
- OTSUKA PHARM CO LTD
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761434 | Voyxact | sibeprenlimab-szsi | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOYXACT | SIBEPRENLIMAB-SZSI | INJECTABLE;INJECTION | 400MG/2ML(200MG/ML) | 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 |
|---|---|---|---|---|---|---|
| VOYXACT | SIBEPRENLIMAB | Otsuka America Pharmaceutical, Inc. | c8a93b32-0676-4704-86dc-cb65f425c6e5 | 2026-03-17 | Warnings, Adverse reactions | BLA761434 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.