Novo Nordisk has asked the FDA to block production of compounded copies of Ozempic, arguing that it’s too difficult to do safely. It’s the latest escalation in a brewing war between pharmaceutical companies and compounders.
Drugmaker Novo Nordisk is taking action to curb the massively popular compounded semaglutide industry, which provides copies of its blockbuster weight-loss drugs Ozempic and Wegovy to patients—often for much lower prices. The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s Demonstrable Difficulties for Compounding lists, which would block compounding pharmacies from producing dupes of the drug.
Unlike generic medications, which are manufactured after drug patents expire, compounded medications are not subject to FDA approval before hitting the market. This means that the FDA cannot vouch for the safety, effectiveness, or quality of compounded drugs before they’re sold to patients. The FDA has received multiple reports of adverse side effects, including hospitalization, related to possible dosing errors associated with compounded semaglutide products.
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