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June 28 : The FDA declined to approve Eton Pharmaceuticalsdehydrated alcohol injection for the treatment of methanol poisoning, citing concerns related primarily to Chemistry Manufacturing and Controls. This is the second Complete Response Letter issued to Eton for this proposed treatment

1L shows the chemical structure, formula and molecular weight for SEQ ID NO: 13

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Key Features Synthetic peptide derived from a naturally occurring gastric protein Widely studied in tissue repair and inflammation-related research models Manufactured under controlled conditions with batch-level quality control Supplied as a lyophilized powder for enhanced stability and storage Applications Soft tissue, muscle, and tendon repair research models Experimental studies involving inflammation and oxidative stress pathways Gastrointestinal and gut permeability research In vitro and analytical investigation of cellular protection mechanisms All applications are strictly limited to laboratory research use only

Meng S, Cao J, Feng Q, et al