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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: avacopan
Trade Name: Tavneos
Date Designated: 06/02/2014
Orphan Designation: Treatment of anti-neutrophil cytoplasmic autoantibodies associated vasculitides (granulomatosis with polyangiitis or Wegener's granulomatosis, microscopic polyangiitis, and Churg-Strauss syndrome).
Orphan Designation Status: Designated/Approved
ChemoCentryx, Inc.
835 Industrial Road, Suite 600
San Carlos, California 94070
United States

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

Marketing approved:

1 Generic Name: avacopan
Trade Name: Tavneos
Marketing Approval Date: 10/07/2021
Approved Labeled Indication: As an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids
Exclusivity End Date: 10/07/2028 
Exclusivity Protected Indication* :  As an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA])
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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