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Injectable and IV Glutathione: Off-Label Use vs Unapproved Drug Injectable glutathione is not FDA-approved as a drug product, which means it cannot be marketed, sold, or administered as a treatment for any medical condition without meeting the criteria for lawful off-label prescribing

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It performed encouragingly in phase 2 as an adjunct to a gluten-free diet, and in 2020 became the first coeliac disease drug to reach phase 3

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