Product Details for: LYFGENIA
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intravenous
1.7-20x10^6CELL/ML
Bag
351(a)
LYFGENIA
Rx
Proper Name
lovotibeglogene autotemcel
lovotibeglogene autotemcel
BLA Number
125788
125788
Applicant
Genetix Biotherapeutics Inc.
Genetix Biotherapeutics Inc.
Original Approval Date
December 8, 2023
December 8, 2023
Date of First Licensure