From CNBC: 2024-10-23 13:52:53

Novo Nordisk has asked the FDA to block compounding pharmacies from making unapproved versions of its weight loss injection Wegovy and diabetes treatment Ozempic, citing safety concerns. Patients have turned to compounded versions due to shortages and high costs of the branded drugs. The FDA is reviewing the petition, which aims to prevent potential risks associated with compounded medications. Novo Nordisk cited instances where compounded versions contained incorrect dosages or no active ingredient at all. The FDA had previously warned about the risks of using compounded versions of drugs like semaglutide. Novo Nordisk argued that compounded semaglutide products pose significant safety risks.

Novo Nordisk’s Wegovy and Ozempic are currently under patent protection, and the company has taken legal action against several clinics and pharmacies over potentially harmful copies of their drugs. The FDA has expressed concerns about overdosing on compounded semaglutide due to dosing errors. Eli Lilly, the maker of Zepbound and Mounjaro, has also sued multiple clinics and pharmacies over knockoff versions of their drugs. The FDA removed tirzepatide from its shortage list, but some pharmacies are still struggling to obtain the branded versions. The FDA is reconsidering its decision to remove tirzepatide from the shortage list in response to legal action from a trade group representing compounders.



Read more at CNBC: Novo Nordisk asks FDA to ban compounded Ozempic, Wegovy copies