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Elevidys
delandistrogene moxeparvovec-rokl
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Elevidys
Proper name
delandistrogene moxeparvovec-rokl
Licence type
351(a)
BLA number
125781
Applicant
Sarepta Therapeutics, Inc.
Center
CBER
Presentations
1
First licensure
June 22, 2023
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.33 10E14 vector genomes (vg)/kg/bodyweight(bw) | Suspension | Intravenous | Single-Dose Vial | Rx | June 22, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 20, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |