← FDA DRUG APPROVALS

FDA NDA · NDA219019

QFITLIA

fitusiran

Sponsor: GENZYME CORP

APPLICATION
NDA219019
TYPE
NDA
ORIGINAL APPROVAL
2025-03-28
LATEST ACTION
2025-03-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

QFITLIA · ReferencePrescription
FITUSIRAN SODIUM EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) · SOLUTION · SUBCUTANEOUS
QFITLIA · ReferencePrescription
FITUSIRAN SODIUM EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-03-28Type 1 - New Molecular Entity · Original · standard — Medication Guide ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →