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Compounded preparations are not FDA-approved finished products, the agency does not verify their safety, effectiveness or quality before marketing, and the FDA distinguishes them from generic drugs, which must establish therapeutic equivalence under section 505(j)

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Mechanistic studies have attributed these effects to the inhibition of nuclear factor-kappa B (NF-B) phosphorylation, a critical upstream regulator of inflammasome priming (Sui et al., 2016)

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