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Aduhelm
aducanumab-avwa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Aduhelm
Proper name
aducanumab-avwa
Licence type
351(a)
BLA number
761178
Applicant
Biogen Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 170MG/1.7ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 7, 2021 |
| 300MG/3ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 7, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |