General MedicationsINTRATHECALStandard
SPINRAZA
NUSINERSEN SODIUM
Standard Dose
EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SPINRAZA is listed in Drugs@FDA under application 209531 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient NUSINERSEN SODIUM Form and strength SOLUTION;INTRATHECAL - EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) Sponsor BIOGEN IDEC Submission history Latest submission status date: 2026-03-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview SPINRAZA is listed in Drugs@FDA under application 209531 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NUSINERSEN SODIUM Form and strength SOLUTION;INTRATHECAL - EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) Sponsor BIOGEN IDEC Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.