On 2 January 2025, the FDA published a Citizen Petition filed by Novo Nordisk seeking to exclude its type 2 diabetes liraglutide injection Victoza® from a proposed list of drugs eligible for compounding. In its petition, Novo Nordisk argues that there is no clinical need to compound liraglutide and that it will not lend well to compounding citing safety concerns.
This follows a separate petition filed by Novo Nordisk in October 2024 requesting inclusion of semaglutide in the Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns. In November 2024, the US Alliance for Pharmacy Compounding (APC) provided a lengthy rebuttal to Novo Nordisk’s assertions arguing that synthetic semaglutide APIs are safe and rigorously regulated, often showing comparable or better impurity profiles than Novo Nordisk’s recombinant APIs.