Application 761375
- Type
- BLA
- Sponsor
- EISAI INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761375 | Leqembi IQLIK | lecanemab-irmb | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | LEQEMBI IQLIK | LECANEMAB-IRMB | INJECTABLE;SUBCUTANEOUS | 360MG/1.8ML(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 |
|---|---|---|---|---|---|---|
| LEQEMBI | LECANEMAB | Eisai Inc. | 9d1ff786-e577-410a-a273-c4d7d0e4e975 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | BLA761375 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.