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Medically accepted indications are uses approved by the United States Food and Drug Administration or listed in one of the references that CMS defines as approved compendia 10 : American Hospital Formulary Service Drug Information DRUGDEX Information System Peer-reviewed medical literature (only allowed for biologics and anti-cancer chemotherapy medications) Common examples of medications prescribed for non-medically accepted indications include the use of fentanyl lollipops/lozenges for non-cancer pain and hydroxychloroquine for coronavirus disease 2019 (COVID-19)
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The gastrointestinal data is from animal models, and the single human ulcerative-colitis dataset regulators reviewed was judged insufficient to establish effectiveness
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