On this page
Lemtrada
alemtuzumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lemtrada
Proper name
alemtuzumab
Licence type
351(a)
BLA number
103948
Applicant
Genzyme Corporation
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 12MG/1.2ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | November 14, 2014 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 7, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |