Novo Nordisk has filed a citizen petition with the FDA to block the compounding of liraglutide, a key ingredient in its diabetes and obesity medications, by outsourcing facilities.
The move intensifies an ongoing legal battle, as Novo Nordisk joins its major competitor Eli Lilly in opposing a recent initiative by the Outsourcing Facilities Association to include liraglutide in the FDA's 503B bulks list for compounding.
The petition, submitted Dec. 20, 2024, argues that liraglutide should be excluded from the 503B bulks list, a registry of substances that outsourcing facilities are permitted to use in compounded medications.
In its petition, Novo Nordisk highlights that the FDA-approved formulations of liraglutide are medically appropriate for the conditions they are prescribed for and there is no clinical need for compounding.
Novo Nordisk also calls for a rescinding of the FDA's 503B Interim Policy Guidance, which allows the compounding of substances not on the 503B bulks list under certain conditions.
The latest move by Novo Nordisk follows Eli Lilly's earlier petition against the inclusion of certain GLP-1 receptor agonists in the 503B list.