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Otarmeni
lunsotogene parvec-cwha
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Otarmeni
Proper name
lunsotogene parvec-cwha
Licence type
351(a)
BLA number
125874
Applicant
Regeneron Pharmaceuticals, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 3x10^13VG/ML | Suspension | Intracochlear | Single-Dose Vial | Rx | April 23, 2026 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 23, 1933 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |