The drugmaker has filed a total of 12 lawsuits against clinics, med spas and compounding pharmacies in the U.S. that claim to offer semaglutide, the active ingredient in Ozempic and Wegovy.
Novo Nordisk holds the patent on semaglutide, and the drugmaker does not supply the ingredient to outside groups, leaving some experts wondering what exactly is being sold to consumers.
The two businesses in the settlements — Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss, both based in Florida — are permanently banned from claiming that their compounded drugs are medicines approved by the Food and Drug Administration, according to Novo Nordisk.
They are also permanently banned from using any Novo Nordisk trademarks or logos in their products as well as any "misleading" advertising, the drugmaker said. Both businesses are required to make the changes immediately.
The settlements come as states have been cracking down on compounded versions of the drug, which they say may contain other ingredients that are not approved by the FDA.
Late last year, Novo Nordisk said that it had conducted tests on compounded products allegedly being sold as semaglutide from two Florida pharmacies. One sample, the drugmaker claimed in a lawsuit filed in November, had a level of unknown impurities of 33%. Another sample had lower levels of the active ingredient than described on the label, along with impurities, according to a separate lawsuit.
The FDA and the World Health Organization have also sounded the alarm about counterfeit versions of the drug.
CORRECTION (Feb. 13, 2024, 1:43 p.m. ET):?A previous version of this article misstated how long the two businesses were given to make the changes required in the settlements. They must be implemented immediately, not within a year.