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FDA relies on the complete, accurate, and timely submission of ADEs to monitor a products safety profile and uphold FDAs mission to protect and promote public health, the FDA wrote, referring to adverse drug events. It said findings were based on an inspection of a Novo Nordisk facility in New Jersey last year

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The trade-off is that compounded medications are not FDA-approved as finished products, though they are prepared under FDA-regulated compounding guidelines and dispensed by licensed pharmacies

Patients experiencing significant GI symptoms may attribute their mood changes to the medication itself rather than to the secondary effects of physical discomfort