On Friday, Novo Nordisk announced the resolution of two lawsuits against businesses that purportedly offered compounded versions of its successful drugs, Ozempic and Wegovy. The pharmaceutical company has initiated a total of 12 lawsuits against various entities in the U.S., including clinics, medical spas, and compounding pharmacies, all claiming to provide semaglutide, the active ingredient found in Ozempic and Wegovy.
Novo Nordisk, holding the patent for semaglutide, does not supply this ingredient to external entities, raising concerns among experts regarding the actual composition of the products sold to consumers.
As part of the settlements with two Florida-based businesses, Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss, Novo Nordisk has secured permanent injunctions preventing them from falsely asserting that their compounded drugs are FDA-approved medicines. Additionally, the businesses are banned from utilizing Novo Nordisk trademarks or logos in their products and engaging in any form of “misleading” advertising. Immediate implementation of these changes is mandated for both businesses.
These settlements coincide with increased scrutiny by states on compounded versions of the drug, citing potential inclusion of FDA-unapproved ingredients. In the previous year, Novo Nordisk reported conducting tests on compounded products from two Florida pharmacies, revealing one sample with 33% unknown impurities and another with lower levels of the active ingredient than indicated on the label, along with impurities.
Concerns over counterfeit versions of the drug have prompted alerts from both the FDA and the World Health Organization. A correction to the initial article clarifies that the mandated changes for the two businesses must be implemented immediately, not within a year.