Novo Nordisk Seeks FDA Restriction on Victoza Compounding Amid Ongoing GLP-1 Supply Issues

Novo Nordisk's Request:
Novo Nordisk has submitted a request to the FDA to restrict U.S. compounders from manufacturing Victoza (liraglutide), a type 2 diabetes injection13.

Supply Issues:
The request comes amid ongoing supply issues with GLP-1 receptor agonists, including liraglutide, despite the stabilization of tirzepatide supply2.

Compounding Policies:
The FDA has clarified compounding policies, allowing temporary compounding of tirzepatide by state-licensed pharmacies and outsourcing facilities until early 2025, but strict legal restrictions will apply afterward2.

Clinical Need:
Novo Nordisk argues that there is no clinical need to allow compounding for liraglutide, emphasizing the complexity and safety risks associated with its production35.

Regulatory Context:
The FDA is actively monitoring drug availability and determining whether demand or projected demand for each drug in shortage exceeds the available supply2.

Sources:

1. https://medwatch.com/News/Pharma_Biotech/article17780809.ece

2. https://www.epocrates.com/online/article/fda-clarifies-compounding-policies-as-glp-1-supply-stabilizes

3. https://www.biospace.com/diabetes

5. https://www.biospace.com/fda/novo-makes-case-to-fda-that-semaglutide-is-too-complex-for-compounders-to-make