STAT+: Court ruling opens door to FDA action against Ozempic compounders
A court ruling has opened the door to FDA action against Ozempic compounders, a major win for Novo Nordisk.
Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.
