{
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      "id": "ind:fda:tibsovo:0",
      "type": "Indication",
      "description": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.",
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          "id": "doc:fda:tibsovo",
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          "documentType": "Regulatory approval",
          "name": "Tibsovo (ivosidenib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. Accessed October 30, 2024.",
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          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Tibsovo (ivosidenib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf. Revised May 2022. Accessed October 6, 2026.",
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          "description": "The description text for all Statements derived from this Indication."
        }
      ]
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  ]
}