← FDA DRUG APPROVALS

FDA NDA · NDA214012

LEQVIO

inclisiran

Sponsor: NOVARTIS

APPLICATION
NDA214012
TYPE
NDA
ORIGINAL APPROVAL
2021-12-22
LATEST ACTION
2026-02-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LEQVIO · ReferencePrescription
INCLISIRAN SODIUM EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-02-12Efficacy · Supplement 18 · priority — Letter ↗AP
2026-02-12Efficacy · Supplement 17 · priority — Letter ↗AP
2025-07-31Efficacy · Supplement 16 · standard — Letter ↗AP
2024-06-06Labeling · Supplement 11 · standard — Letter ↗AP
2023-07-07Labeling · Supplement 9 · standard — Letter ↗AP
2023-02-17Labeling · Supplement 6 · standard — Letter ↗AP
2022-06-06Labeling · Supplement 2 · standard — Letter ↗AP
2021-12-22Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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