Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make.
Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. But Novo argued that semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, should be on the FDA’s “Demonstrable Difficulties for Compounding Lists,” which are lists of complex medications that compounders are not allowed to make regardless of shortages, according to documents the agency posted this week.
The FDA still has to make a decision on whether to officially place semaglutide on the lists. The agency did not immediately respond to a request for comment.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
View All Plans
