Search Orphan Drug Designations and Approvals
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Generic Name: | Emapalumab-lzsg | ||||||||||||||||
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Trade Name: | GAMIFANT™ | ||||||||||||||||
Date Designated: | 03/26/2010 | ||||||||||||||||
Orphan Designation: | Treatment of hemophagocytic lymphohistiocytosis | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Swedish Orphan Biovitrum AB SE-112 75 Stockholm Stockholm Sweden The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Emapalumab-lzsg |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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