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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: iptacopan
Trade Name: Fabhalta
Date Designated: 05/18/2020
Orphan Designation: Treatment of C3 glomerulopathy
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: iptacopan
Trade Name: Fabhalta
Marketing Approval Date: 03/20/2025
Approved Labeled Indication: treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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