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Kebilidi
eladocagene exuparvovec-tneq
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kebilidi
Proper name
eladocagene exuparvovec-tneq
Licence type
351(a)
BLA number
125722
Applicant
PTC Therapeutics
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 5.6x10^11VG/ML | Suspension | Intraputaminal | Single-Dose Vial | Rx | November 13, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 13, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |