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General MedicationsSUBCUTANEOUSStandard

QFITLIA

FITUSIRAN SODIUM

Standard Dose
EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview QFITLIA is listed in Drugs@FDA under application 219019 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FITUSIRAN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) Sponsor GENZYME CORP Submission history Latest submission status date: 2025-03-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview QFITLIA is listed in Drugs@FDA under application 219019 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FITUSIRAN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) Sponsor GENZYME CORP Submission history Latest submission status date: 2025-03-28 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
QFITLIA (FITUSIRAN SODIUM) | Drug Monograph | MedicHelpline