Kimberly Redmond//February 22, 2024//
Novo Nordisk's semaglutide injection Ozempic. - DEPOSIT PHOTOS
Novo Nordisk's semaglutide injection Ozempic. - DEPOSIT PHOTOS
Kimberly Redmond//February 22, 2024//
Novo Nordisk previously sued several businesses for allegedly selling copycat versions of its blockbuster weight loss drug Wegovy and popular diabetes shot Ozempic. Now, the Danish drugmaker settled two of those cases.
The pharmaceutical company with U.S. headquarters in Plainsboro reached settlements earlier this month with Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss. The agreements immediately bar the Florida-based businesses from claiming their compounded drugs are approved by the U.S. Food and Drug Administration.
The resolution also prohibits them from “misleading” advertising and using any Novo Nordisk trademarks or logos in their products.
As the sole patent holder of semaglutide – the active ingredient in Wegovy and Ozempic – Novo Nordisk has said it is not supplied to outside entities.
Over the past year, Novo Nordisk filed 12 lawsuits against clinics, medical spas and compounding pharmacies across the country that claimed to offer semaglutide. Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss are the first defendants to settle.
In a statement to NJBIZ, Novo Nordisk said it is “very pleased with the outcome of these final judgement and permanent injunction orders entered by the courts against these defendants who were engaged in false advertising, trademark infringement and/or unlawful marketing of non-FDA approved compounded products claiming to contain semaglutide.”
“The defendants’ unlawful marketing practices, including the use of misleading advertising and Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception, as well as potential safety concerns. Consistent with our commitment to patient safety, Novo Nordisk will continue to pursue legal action against other entities engaged in similar conduct,” the statement continued.
Additional details on the terms of the agreements or the status of the other suits was not immediately available from Novo Nordisk.
With a continuing shortage of Wegovy and Ozempic, consumers are increasingly turning to compounding pharmacies for cheaper, copycat versions of the drugs. The trend prompted the FDA to issue warnings about the safety risk of using unauthorized versions, saying it has received reports of adverse health reactions related to modified, or “compounded,” variations.
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Under federal law, the FDA permits compounding pharmacies to prepare compounded versions of medications currently listed in short supply.
However, the agency has emphasized that compounded semaglutide is neither FDA-approved or evaluated for safety, effectiveness or quality. At this time, only three authorized products are available by prescription: injectables Ozempic and Wegovy as well as oral tablet Rybelsus.
According to NBC News, Novo Nordisk said late last year it found that compounded products claiming to contain semaglutide were impure, some by as much as 33%. Another sample had lower levels of the active ingredient than described on the label, along with impurities.