Novo Nordisk aims to crack down on compounded versions of semaglutide
Written by: fiercepharma.com
Original Article
Three weeks after the FDA warned that some pharmacies are making unauthorized versions of Novo Nordisk’s highly demanded diabetes and obesity drugs, the company has filed suit against five outlets in the United States.
In Florida, New York, Tennessee and Texas, Novo filed separate suits on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of Ozempic and Wegovy, the company said in a release.
In an email, a representative for Novo Nordisk said the company plans to take action against other makers and sellers of compounded copycats.
“We are preparing to file additional lawsuits in the coming days and weeks against medical spas, weight-loss clinics and compounding pharmacies,” the Novo spokesperson said.
As the FDA explained last month, some pharmacies are permitted to make compounded versions of treatments which are having supply shortages. But in the rush to provide these popular medications, primarily for patients looking to lose weight, some pharmacies are making versions that do not include semaglutide—the key active ingredient of the GLP-1 drugs.
Novo Nordisk is taking action against spas and clinics that are not informing patients that they are using compounded versions of Ozempic and Wegovy.
Some companies are making their knockoffs with salt forms of semaglutide—called semaglutide sodium or semaglutide acetate—which have not been proven to be safe or effective. The agency has received adverse event reports after patients have used some of these compounded versions of semaglutide.
“These unlawful marketing and sales practices, including the use of Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception as well as potential safety concerns,” Novo said in its release.
Written by: fiercepharma.com
Original Article