The FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet the requirements of the federal Food, Drug, and Cosmetic (FD&C) Act. Salt forms have not been shown to be safe and effective. The FDA has received adverse event reports after patients used compounded semaglutide
74 Exenatide therapy was associated with lower cardiac enzyme values during the first 72 hours and a reduction in infarct size according to cardiac MRI at 1 month compared with placebo
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A six-month cynomolgus monkey study of two DAC-modified peptides concluded that they produced no evidence of immunogenic or immunotoxic effects but FDA notes that the data description is vague, that the absence of neutralising antibodies appears to apply only to the other compound in that study, and that no assessment of plasma GH or IGF-1 was provided for the CJC-1295 DAC-treated monkeys to demonstrate that pharmacological activity even persisted through the dosing period [11]
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