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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fitusiran
Trade Name: Qfitlia
Date Designated: 08/16/2013
Orphan Designation: Treatment of hemophilia A
Orphan Designation Status: Designated/Approved
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: fitusiran
Trade Name: Qfitlia
Marketing Approval Date: 03/28/2025
Approved Labeled Indication: for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors
Exclusivity End Date: 03/28/2032 
Exclusivity Protected Indication* :  for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A with or without factor VIII inhibitors
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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