{"@type": "dcat:Dataset", "accessLevel": "public", "accrualPeriodicity": "R/P1Y", "bureauCode": ["009:10"], "contactPoint": {"@type": "vcard:Contact", "fn": "Division of Drug Information", "hasEmail": "mailto:druginfo@fda.hhs.gov"}, "description": "Besponsa (inotuzumab ozogamicin) is an intravenous prescription drug, supplied as a lyophilized powder for injection. It's an immunoconjugate that targets CD22 on cancer cells, leading to DNA damage and cell death. Manufactured by Wyeth Pharmaceuticals LLC (a Pfizer subsidiary), it's used in treating relapsed or refractory acute lymphoblastic leukemia. This information was generated using AI and is provided for informational and research purposes only.", "distribution": [{"@type": "dcat:Distribution", "description": "\n        Access the FDA dataset for Inotuzumab ozogamicin \u2014 ANDA 761040 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761040", "mediaType": "text/html", "title": "Inotuzumab ozogamicin"}], "identifier": "ANDA761040", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "fda", "health-care", "medications", "public-health"], "landingPage": "https://www.fda.gov/drugs", "license": "https://open.fda.gov/license", "modified": "2025-03-17", "programCode": ["009:002"], "publisher": {"@type": "org:Organization", "name": "U.S. Food and Drug Administration"}, "theme": ["FDA"], "title": "Inotuzumab ozogamicin"}