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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ivosidenib
Trade Name: Tibsovo
Date Designated: 05/20/2020
Orphan Designation: Treatment of myelodysplastic syndromes
Orphan Designation Status: Designated/Approved
Servier Pharmaceuticals LLC
200 Pier Four Blvd
Boston, Massachusetts 02210
United States

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

Marketing approved:

1 Generic Name: ivosidenib
Trade Name: Tibsovo
Marketing Approval Date: 10/24/2023
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
Exclusivity End Date: 10/24/2030 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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