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Myozyme
alglucosidase alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Myozyme
Proper name
alglucosidase alfa
Licence type
351(a)
BLA number
125141
Applicant
Genzyme Corporation
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 50MG | For Injection | Intravenous | Single-Dose Vial | Disc | April 28, 2006 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 28, 2013 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |