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Purple Book
Database of Licensed Biological Products

Product Details for: Luxturna
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001InjectionIntraocular1.5X10 TO 11 MLSingle-Dose Vial351(a)LuxturnaRx

Proper Name
Voretigene Neparvovec

BLA Number
125610

Applicant
Spark Therapeutics, Inc.

Original Approval Date
December 19, 2017

Date of First Licensure