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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: 06/09/2015
Orphan Designation: Treatment of acute myeloid leukemia (AML)
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: 07/20/2018
Approved Labeled Indication: TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Exclusivity End Date: 07/20/2025 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
2 Generic Name: ivosidenib
Trade Name: TIBSOVO
Marketing Approval Date: 05/02/2019
Approved Labeled Indication: TIBSOVO is indicated for the treatment of newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are >= 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Exclusivity End Date: 05/02/2026 
Exclusivity Protected Indication* :  TIBSOVO is indicated for the treatment of newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are >= 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
3 Generic Name: ivosidenib
Trade Name: Tibsovo
Marketing Approval Date: 05/25/2022
Approved Labeled Indication: In combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
Exclusivity End Date: N/A  
*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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