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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219019
Company: GENZYME CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QFITLIA FITUSIRAN SODIUM EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
QFITLIA FITUSIRAN SODIUM EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/28/2025 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219019s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219019Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219019Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/28/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219019s000lbl.pdf
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