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These lignans, including schisandrin B (Sch B), schisandrin A (Sch A), and deoxyschisandrin (DS), have been demonstrated to ameliorate MASLD through multiple mechanisms: activation of PPAR- to promote fatty acid (FA) oxidation, inhibition of the LXR-/sterol regulatory element-binding protein 1c (SREBP-1c)/FAS pathway to reduce de novo lipogenesis, activation of the AMPK/mTOR autophagy pathway to decrease hepatic lipid accumulation, and suppression of pro-inflammatory cytokines to attenuate hepatic inflammation

That law created a new section, 503B, in the Federal Food, Drug, and Cosmetic Act

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Review Type: Standard Review Submission Date: April 1, 2024 Review Status: FDA accepted the application on June 9, 2024