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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: emapalumab-lzsg
Trade Name: Gamifant
Date Designated: 03/26/2010
Orphan Designation: Treatment of hemophagocytic lymphohistiocytosis
Orphan Designation Status: Designated/Approved
Swedish Orphan Biovitrum AB
SE-112
75 Stockholm
Stockholm
Sweden

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

Marketing approved:

1 Generic Name: emapalumab-lzsg
Trade Name: Gamifant
Marketing Approval Date: 11/20/2018
Approved Labeled Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
Exclusivity End Date: 11/20/2025 
Exclusivity Protected Indication* :  GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
2 Generic Name: emapalumab-lzsg
Trade Name: Gamifant
Marketing Approval Date: 06/27/2025
Approved Labeled Indication: treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still¿s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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