{"@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": "Mavyret is a prescription medication containing glecaprevir and pibrentasvir, used to treat chronic hepatitis C virus (HCV) infection in adults. It comes as oral pellets, typically taken once daily for 8-16 weeks depending on the HCV genotype and patient factors. Manufactured by AbbVie Inc., it works by inhibiting HCV proteins to stop viral replication. 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 Glecaprevir and pibrentasvir \u2014 ANDA 209394 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209394", "mediaType": "text/html", "title": "Glecaprevir and pibrentasvir"}], "identifier": "ANDA209394", "issued": "2016-09-16", "keyword": ["drug", "drug-manufacturers", "drug-safety", "medications", "prescription-drugs"], "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": "Glecaprevir and pibrentasvir"}