Quick answers
- What is Lunsotogene parvec-cwha used for?
- The FDA-approved label (Otarmeni, Regeneron Pharmaceuticals, Inc., April 27, 2026) says: “OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lunsotogene parvec-cwha have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lunsotogene parvec-cwha?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lunsotogene parvec-cwha been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lunsotogene parvec-cwha?
- 1 company lists prescription products of Lunsotogene parvec-cwha in the FDA NDC Directory, including Regeneron Pharmaceuticals, Inc..
What Lunsotogene parvec-cwha is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. …
— FDA label: Otarmeni, Regeneron Pharmaceuticals, Inc., effective April 27, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intracochlear |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Otarmeni |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Regeneron Pharmaceuticals, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125874 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2741622, 2741629 |
|---|---|
| SPL set ID of the quoted label | a7a5e936-ab4a-4609-ac10-96efedc89035 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125874 |
| Active ingredients (FDA) | LUNSOTOGENE PARVEC |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Otarmeni, Regeneron Pharmaceuticals, Inc., effective April 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →