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 |
| 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. |
| 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. |
| 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. |
| 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* : | |
| 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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