Spinraza

Treats spinal muscular atrophy (SMA). NDA 209531, held by Biogen. Nusinersen Sodium.

As of Nov 13, 2026, NDA 209531 (Spinraza), held by Biogen, was first approved by FDA on Dec 23, 2016, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2016
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Mar 27, 2026	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 16, 2020	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 14, 2018	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 23, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

3 strengths and forms


SpinrazaEQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) · solution;intrathecal	Nusinersen Sodium	RxReference drug
SpinrazaEQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) · solution;intrathecal	Nusinersen Sodium	RxReference drug
SpinrazaEQ 50MG BASE/5ML (EQ 10MG BASE/ML) · solution;intrathecal	Nusinersen Sodium	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Mar 27, 2026	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 10, 2024	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 10, 2024	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 17, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
Jun 16, 2020	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 17, 2019	Supplement 8Labeling · Standard review	Approved	Label Letter
Jun 17, 2019	Supplement 7Labeling · Standard review	Approved	Label Letter
Oct 10, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label
May 14, 2018	Supplement 4Labeling · Standard review	Approved	Label Letter
May 14, 2018	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 21, 2017	Supplement 2Labeling · Standard review	Approved	Letter Label
Dec 23, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 209531
Drugs@FDA: Overview at FDA
Company: Biogen

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters