Product Details for: OTARMENI

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intracochlear
3x10^13VG/ML
Single-Dose Vial
351(a)
OTARMENI
Rx
Proper Name
lunsotogene parvec-cwha
BLA Number
125874
Applicant
Regeneron Pharmaceuticals, Inc.
Original Approval Date
April 23, 2026
Date of First Licensure
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