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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
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
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.
 
Generic Name:  ivosidenib
Trade Name:  TIBSOVO
Date Designated:  06/09/2015
Orphan Designation:  Treatment of acute myeloid leukemia (AML)
Orphan Designation Status:  Designated/Approved
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.
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.
 
Generic Name:  ivosidenib
Trade Name:  Tibsovo
Date Designated:  06/09/2015
Orphan Designation:  Treatment of acute myeloid leukemia (AML)
Orphan Designation Status:  Designated/Approved
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:     
Exclusivity Protected Indication* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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