Product Details for: Casgevy
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intravenous
4-13 10^6 CELL/ML
Single-Dose Vial
351(a)
Casgevy
Rx
Proper Name
Exagamglogene autotemcel
Exagamglogene autotemcel
BLA Number
125787
125787
Applicant
Vertex Pharmaceuticals Inc
Vertex Pharmaceuticals Inc
Original Approval Date
December 8, 2023
December 8, 2023
Date of First Licensure