Product Details for: Skysona
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
2-30 10^6 CELL/ML
Bag
351(a)
Skysona
Rx
Proper Name
elivaldogene autotemcel
elivaldogene autotemcel
BLA Number
125755
125755
Applicant
Genetix Biotherapeutics Inc.
Genetix Biotherapeutics Inc.
Original Approval Date
September 16, 2022
September 16, 2022
Date of First Licensure
09/16/2022
09/16/2022