Novo tells FDA compounded semaglutide too difficult to make

In its continuing effort against compounding pharmacies manufacturing semaglutide, Novo Nordisk (NVO) has told the U.S. FDA that the drug is so difficult to produce, it can pose safety risks if not manufactured in the correct fashion.
The Danish drugmaker has asked the agency to have semaglutide placed on the Demonstrable Difficulties for Compounding List.
“Semaglutide products belong on these lists due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing,” a filing from Novo’s attorneys, Covington & Burling, reads.
Semaglutide is the active ingredient in Novo’s blockbuster weight loss and type 2 diabetes drugs, Wegovy and Ozempic.
Both Novo and rival Eli Lilly (LLY), which manufactures tirzepatide as Zepbound for weight loss and Mounjaro for diabetes, dealt with shortages of their respective therapies for most of 2024 due to their immense popularity. However, the drugs are no longer in shortage.
Compounders are permitted to make medications still under patent protection if they are on an FDA drug shortages list.
Lilly recently sued three compounders for continuing to make and sell compounded tirzepatide.

Tags: LLY