General MedicationsSUBCUTANEOUSStandard
LEQVIO
INCLISIRAN SODIUM
Standard Dose
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview LEQVIO is listed in Drugs@FDA under application 214012 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient INCLISIRAN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) Sponsor NOVARTIS Submission history Latest submission status date: 2026-02-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview LEQVIO is listed in Drugs@FDA under application 214012 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient INCLISIRAN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) Sponsor NOVARTIS Submission history Latest submission status date: 2026-02-12 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.