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The U.S. Food and Drug Administration (FDA) granted approval for Lactulose in 1977 for use in portal-systemic Hepatic Encephalopathy (HE), covering all stages from hepatic pre-coma to coma.
In the European Union, lactulose is widely marketed as an osmotic laxative and its use for hepatic encephalopathy is recognized in clinical practice and guidelines (EASL, AASLD) but comes under national-level approvals, not EMA central registration.
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