Otarmeni Injection, Solution
Product Images NDC 61755-062

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Otarmeni (NDC 61755-062). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Regeneron Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Otarmeni 01)

An instructional illustration showing a pair of hands drawing a solution from a vial into a syringe, likely demonstrating preparation of an injection dose. The syringe has measurement markings and the vial is held steady between the fingers.*

FDA Label Image

Chemical Structure (Otarmeni 02)

An instructional diagram showing a syringe drawing a suspension from a vial. A magnified inset highlights the needle bevel, labeled as pointing down, demonstrating proper needle orientation when withdrawing the suspension.*

FDA Label Image

Figure 2 (Otarmeni 03)

An anatomical illustration showing the inner ear region highlighting a fenestration site labeled as 0.5 to 1.0 mm in size. This diagram likely relates to the intracohear route of administration for the injection solution OTARMENI (lunsotogene parvec-cwha).*

FDA Label Image

Figure 3 (Otarmeni 04)

An anatomical illustration showing the tight fit of a catheter to the round window membrane, likely related to the intracoachlear injection process for OTARMENI (lunsotogene parvec-cwha). The diagram highlights the catheter positioned within the ear anatomy for drug delivery.*

FDA Label Image

Figure 4 (Otarmeni 05)

An instructional illustration showing a flexible catheter-like device used for intraco... insertion. A close-up inset highlights the correct depth for insertion into the round window, emphasizing precise placement of the tip. The diagram outlines the shape and markings along the length of the instrument.*

FDA Label Image

Principal Display Panel (0.63 mL Vial Carton Bag Label)

Label for Otarmeni (lunsotogene parvec-cwha) injection, solution with a strength of 3.0 x 10^13 vg/mL. It is a suspension for intracochlear infusion supplied in a single-dose vial containing 0.63 mL. The label indicates storage frozen at -80°C and is manufactured by Regeneron Pharmaceuticals, Inc. The label includes an NDC number, barcode, and QR code.*

FDA Label Image

Principal Display Panel (0.63 mL Vial Carton)

Packaging label for OTARMENI injection, solution for intracocheral infusion, containing lunsotogene parvec-cwha at a strength of 3.0 x 10^13 vg/mL. The label indicates a single-dose vial with 0.63 mL per vial, labeled by Regeneron Pharmaceuticals, Inc. It notes it is package 1 of 2 and requires an administration kit supplied separately.*

FDA Label Image

Principal Display Panel (0.63 mL Vial Label)

Label for Otarmeni 3.0 x 10¹³ vg/mL (lunsotogene parvec-cwha) injection, solution for intracocheral infusion. It is a single-dose vial containing 0.63 mL per vial. Label includes NDC 61755-062, Rx only status, manufacturer Regeneron Pharmaceuticals, Inc., and placeholders for lot number and expiration date.*

FDA Label Image

Principal Display Panel (Device Kit Carton)

Packaging label for OTARMENI administration kit containing lunsotogene parvec-cwha injection, solution for intracochlear infusion. The label includes dosage form details, contents of the kit such as syringes and catheter, usage caution and notes. It is labeled for prescription use only and manufactured by Regeneron Pharmaceuticals, Inc.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.