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Leqembi IQLIK
lecanemab-irmb
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Leqembi IQLIK
Proper name
lecanemab-irmb
Licence type
351(a)
BLA number
761375
Applicant
Eisai, Incorporated
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 250MG/1.25ML (200MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | July 13, 2026 |
| 360MG/1.8ML (200MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | August 29, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |