A federal court in Texas has bolstered Novo Nordisk’s efforts to limit the production and sale of compounded versions of its GLP-1 drugs, Wegovy and Ozempic.
Here are five notes:
- A federal judge in Texas denied a compounding trade association’s motion to pause the FDA’s determination that semaglutide is no longer in shortage, according to an April 25 news release from Novo Nordisk.
- The ruling allows the FDA to immediately take enforcement action against 503A pharmacies manufacturing “knockoff” versions of semaglutide for individual prescriptions.
- Larger-scale 503B pharmacies that produce compounded drugs in bulk have until May 22 before the FDA can take enforcement actions. After that, entities can be subject to product seizures and warning letters.
- This decision follows another federal court ruling in Texas that permanently barred MediOak Pharmacy, a 503A facility, from making or selling compounded semaglutide.
- Novo Nordisk has filed over 100 legal actions across 32 states, citing patient safety and the need to curb potentially dangerous semaglutide copies, the release said.
