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Lamzede
velmanase alfa-tycv
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lamzede
Proper name
velmanase alfa-tycv
Licence type
351(a)
BLA number
761278
Applicant
Chiesi Farmaceutici S.p.A.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG | For Injection | Intravenous | Single-Dose Vial | Rx | February 16, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 16, 2030 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |