Search Orphan Drug Designations and Approvals
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Generic Name: | ivosidenib | ||||||||||||||||
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Trade Name: | TIBSOVO | ||||||||||||||||
Date Designated: | 06/09/2015 | ||||||||||||||||
Orphan Designation: | Treatment of acute myeloid leukemia (AML) | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | ivosidenib |
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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 |
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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 |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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