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What safety data or adverse event reporting requirements will the FDA propose

Nauck et al., 1986)

In pregnant rabbits given 0.2, 2, 22, 156, or 260 mcg/kg/day exenatide during fetal organogenesis, irregular fetal skeletal ossifications were observed at 2 mcg/kg/day, a dose yielding systemic exposure up to 12-times the human exposure from the MRHD of BYETTA based on AUC comparison

Key takeaways Wegovy (semaglutide) side effects typically last two to four weeks