Danish pharma giant Novo Nordisk has asked the Food and Drug Administration (FDA) to stop compounding pharmacies from manufacturing versions of its weight-loss and diabetes drugs, claiming the main compound is too complex to replicate safely.
In the Oct. 22 request, Novo Nordisk asked the FDA to include semaglutide on its Demonstrable Difficulties for Compounding (DDC) lists. Semaglutide is the active ingredient in the company’s weight loss drug Wegovy and diabetes treatment Ozempic. There has been a shortage of both drugs in the United States for most of this year.
Compounding involves mixing or altering ingredients to create a medication tailored for a specific patient. Compounded drugs are often sold at vastly lower prices than the branded versions. When a brand-name medication is in shortage, compounding pharmacies can also prepare copies of the drug if they meet FDA requirements….