The U.S. Food and Drug Administration announced that it will refrain from taking action against compounding pharmacies producing replicas of Novo Nordisk’s weight-loss medication Wegovy until a federal court issues its ruling in a lawsuit against the agency. Last month, the FDA disclosed that there was no longer a shortage of Novo’s Wegovy and diabetes drug Ozempic, which are both semaglutide, and granted compounding pharmacies a window of 60 to 90 days to discontinue manufacturing copies of these drugs. Under U.S. regulations, compounding pharmacies are permitted to create and distribute significant quantities of brand-name medications when they are scarce. The Outsourcing Facility Association, a body representing compounding pharmacies, subsequently sued the FDA over its decision and sought an injunction to allow the continued production of Wegovy replicas. In a recent update, the FDA specified that state-licensed compounding pharmacies and outsourcing facilities have until April 22 and May 22, respectively, or until the court rules on the injunction, to halt the production of Wegovy replicas, whichever is later. A federal judge declined an injunction that would have permitted compounding pharmacies to continue making copies of Eli Lilly’s popular weight-loss drug Zepbound, known as tirzepatide. The compounding association has filed an appeal to challenge this decision in the 5th U.S. Circuit Court of Appeals. The judge is expected to rule on the association’s request for an injunction in the semaglutide lawsuit later this year.
