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The matter was remanded back to FDA for reconsideration, and FDA issued a decision in December 2024 confirming the drug shortage was resolved

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The mechanism of action has been determined that KPV inhibits the activation of NF-kappaB and MAP kinase inflammatory signaling pathways, and reduces pro-inflammatory cytokine secretionacts via PepT1 expressed in immune and intestinal epithelial cells..[and] reduces the incidence of DSS- and TNBS-induced colitis indicated by a decrease in pro-inflammatory cytokine expression (Dalmasso et al., 2008)

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