Novo Nordisk Urges FDA to Ban Compounded Versions of Ozempic and Wegovy
The pharmaceutical company argues that compounded semaglutide poses significant safety risks due to its complexity.
- Novo Nordisk has requested the FDA to add semaglutide to its 'Demonstrable Difficulties for Compounding Lists,' which would prevent pharmacies from producing compounded versions of the drug.
- The company cites safety concerns, including impurities and incorrect dosages, as reasons for the ban on compounded versions of its drugs Ozempic and Wegovy.
- Compounded semaglutide has become popular due to shortages and high costs of the branded drugs, with compounded versions offering a more affordable alternative.
- The FDA has yet to make a decision on the request, but has acknowledged potential risks associated with compounded GLP-1 drugs like semaglutide.
- Novo Nordisk's action is part of a broader legal effort to curb the production and sale of unapproved versions of its weight loss and diabetes medications.