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FDA NDA · NDA209531

SPINRAZA

nusinersen

Sponsor: BIOGEN

APPLICATION
NDA209531
TYPE
NDA
ORIGINAL APPROVAL
2016-12-23
LATEST ACTION
2026-03-27
ROUTE
INTRATHECAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SPINRAZA · ReferencePrescription
NUSINERSEN SODIUM EQ 50MG BASE/5ML (EQ 10MG BASE/ML) · SOLUTION · INTRATHECAL
SPINRAZA · ReferencePrescription
NUSINERSEN SODIUM EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) · SOLUTION · INTRATHECAL
SPINRAZA · ReferencePrescription
NUSINERSEN SODIUM EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) · SOLUTION · INTRATHECAL

Approval history

2026-03-27Efficacy · Supplement 16 · standard — Label ↗AP
2024-04-10Labeling · Supplement 14 · standard — Letter ↗AP
2024-04-10Labeling · Supplement 13 · standard — Letter ↗AP
2023-02-17Labeling · Supplement 11 · standard — Letter ↗AP
2020-06-16Efficacy · Supplement 10 · standard — Letter ↗AP
2019-06-17Labeling · Supplement 8 · standard — Letter ↗AP
2019-06-17Labeling · Supplement 7 · standard — Letter ↗AP
2018-10-10Labeling · Supplement 5 · standard — Label ↗AP
2018-05-14Efficacy · Supplement 3 · standard — Letter ↗AP
2018-05-14Labeling · Supplement 4 · standard — Letter ↗AP
2017-11-21Labeling · Supplement 2 · standard — Label ↗AP
2016-12-23Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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