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Casgevy
Exagamglogene autotemcel
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Casgevy
Proper name
Exagamglogene autotemcel
Licence type
351(a)
BLA number
125787
Applicant
Vertex Pharmaceuticals Inc
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 4-13 10^6 CELL/ML | Suspension | Intravenous | Single-Dose Vial | Rx | December 8, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | January 16, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |