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Prescription medicine

Nusinersen

Brand names: Spinraza

Drug class: Survival Motor Neuron-2-directed RNA Interaction, Antisense Oligonucleotide

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2016First FDA approval on file

Quick answers

What is Nusinersen used for?
The FDA-approved label (Spinraza, Biogen Inc., March 31, 2026) says: “SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Nusinersen 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 Nusinersen?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Nusinersen been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Nusinersen?
1 company lists prescription products of Nusinersen in the FDA NDC Directory, including Biogen Inc..

What Nusinersen is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients

— FDA label: Spinraza, Biogen Inc., effective March 31, 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 formsInjection, solution
RouteIntrathecal
Prescription products3 in the FDA NDC Directory
Brand namesSpinraza

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA209531
SPINRAZA		 BiogenDecember 23, 2016 11, latest March 27, 2026
2026: Efficacy · 2024: Labeling · 2024: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1863560, 1863565, 2739995, 2739998, 2740001, 2740004
SPL set ID of the quoted labeldd70cd5f-b0fc-4ba4-a5ea-89a34778bd94
FDA labels (SPL)1
FDA applicationsNDA209531
Active ingredients (FDA)NUSINERSEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Spinraza, Biogen Inc., effective March 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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