Key Points
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 patientsoften for much lower prices...
The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agencys Demonstrable Difficulties for Compounding (DDC) lists, which would block compounding pharmacies from producing dupes of the drug..
In a filing posted by the agency on Tuesday, lawyers for Novo Nordisk reason that semaglutide belongs on these lists due to the complexities associated with their formulations, among other reasons...
In the US, when the FDA declares that a drug is in shortage, certain licensed pharmacies are permitted to make compounded versions of the medication, which are mixed in-house and are supposed to contain the same active ingredients as the original drug...
A trade group called the Outsourcing Facilities Association filed a lawsuit in a Texas federal court against the FDA, claiming that tirzepatide is still in short supply, and ending the shortage is abruptly depriving patients of a much-needed treatment and artificially raising drug prices...
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