Drugplain

ITVISMA 40000000000000 [arb'U]/mL

onasemnogene abeparvovec-brve · INJECTION, SUSPENSION · Novartis Gene Therapies, Inc.

No Recall History
Plain English

Itvisma is a gene therapy injection administered directly into the spinal fluid to treat spinal muscular atrophy (SMA), a rare genetic disorder that affects nerve cells controlling muscle movement. It is a one-time treatment designed to provide a functional copy of the missing or defective gene responsible for SMA.

Key Facts

Brand Name
ITVISMA
Generic Name
onasemnogene abeparvovec-brve
NDC Code (Product)
71894-200
Manufacturer
Novartis Gene Therapies, Inc.
Strength
40000000000000 [arb'U]/mL
Dosage Form
INJECTION, SUSPENSION
Route
INTRATHECAL
Marketing Status
Application #
BLA125856
Marketing Start
11/24/2025

Recall History

No Recall History

Frequently Asked Questions

What is ITVISMA used for?

Itvisma is a gene therapy injection administered directly into the spinal fluid to treat spinal muscular atrophy (SMA), a rare genetic disorder that affects nerve cells controlling muscle movement. It is a one-time treatment designed to provide a functional copy of the missing or defective gene responsible for SMA.

Is ITVISMA a controlled substance?

ITVISMA is not classified as a controlled substance by the DEA.

What is the generic name for ITVISMA?

The generic name for ITVISMA is onasemnogene abeparvovec-brve. There are no other listed brand versions of onasemnogene abeparvovec-brve.

What is the NDC code for ITVISMA 40000000000000 [arb'U]/mL?

The NDC (National Drug Code) for ITVISMA 40000000000000 [arb'U]/mL is 71894-200, listed by Novartis Gene Therapies, Inc..

Product NDC

71894-200

Package NDC

71894-200-02

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)