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Fabrazyme
agalsidase beta
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Fabrazyme
Proper name
agalsidase beta
Licence type
351(a)
BLA number
103979
Applicant
Genzyme Corporation
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 35MG | For Injection | Intravenous | Single-Dose Vial | Rx | April 24, 2003 |
| 5MG | For Injection | Intravenous | Single-Dose Vial | Rx | October 10, 2003 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 11, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |