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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: 07/31/2020
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
Bldg. 315/5150A
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: 12/05/2023
Approved Labeled Indication: Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)
Exclusivity End Date: 12/05/2030 
Exclusivity Protected Indication* :  Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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