U.S. FDA to Hold Off Action on Weight-loss Drug Copies Pending Court Ruling
The U.S. Food and Drug Administration (FDA) said on Monday it will not take action against compounding pharmacies making copies of Novo Nordisk’s weight-loss drug Wegovy until a federal court delivers its ruling in a lawsuit against the agency.
The health regulator announced last month that there was no longer a shortage of Novo’s Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, and gave compounding pharmacies 60 to 90 days to cease making copies of the drugs.
U.S. regulations allow compounding pharmacies to manufacture and sell large quantities of name-brand medicines as long as they are in short supply.
The Outsourcing Facility Association, which represents compounding pharmacies, later sued the FDA over its decision and filed for an injunction that would allow compounding pharmacies to keep making copies of Wegovy.
In its Monday update, the FDA clarified that state-licensed compounding pharmacies and outsourcing facilities—which make compounded drugs in bulk—have until April 22 and May 22 respectively, or until the court decides on the injunction to stop making Wegovy copies, whichever comes later.