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Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver scarring (fibrosis)

Is there a basis to conclude, for each FDA-approved product that includes the nominated bulk drug substance, that: (a) an attribute of the FDA-approved drug product makes it medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation, and (b) the drug product proposed to be compounded is intended to address that attribute