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Leqembi
lecanemab-irmb
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Leqembi
Proper name
lecanemab-irmb
Licence type
351(a)
BLA number
761269
Applicant
Eisai, Incorporated
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200MG/2ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | January 6, 2023 |
| 500MG/5ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | January 6, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |