MONDAY, Feb. 12, 2024 (HealthDay News) — Novo Nordisk has settled lawsuits against two Florida businesses that claimed to sell copycat versions of its popular weight-loss drugs Ozempic and Wegovy.
The Danish drugmaker announced the settlements Friday, according to NBC News.
The move capped a legal battle that began in late November when the company filed 12 lawsuits against clinics, medical spas and compounding pharmacies in the United States that claimed to offer semaglutide, the active ingredient in Ozempic and Wegovy.
Novo Nordisk, which holds the patent on semaglutide, does not supply the ingredient to outside groups, NBC News noted. Semaglutide is used to treat type 2 diabetes and is a popular, injectable weight-loss drug.
With the settlements announced last week, Florida-based Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss are immediately barred from claiming that their compounded drugs have approval from the U.S. Food and Drug Administration, Novo Nordisk said.
They are also forbidden from "misleading" advertising and using any Novo Nordisk trademarks or logos in their products.
In addition to this, the defendants must prominently disclose in any advertising or marketing materials for unapproved compounded semaglutide drugs have not been reviewed by the FDA for safety, effectiveness and quality, and that other FDA-approved semaglutide medicines are available, the company said. The defendants must do this for a year.
Compounded drugs are custom-made. Ingredients are combined, mixed or altered for an individual patient.
While these drugs are not FDA-approved, they are often sought when approved medications are in short supply. As use of semaglutide for weight control has soared, many patients with diabetes who depend on it to control their blood sugar as well as those seeking to slim down have had trouble getting their prescriptions filled.
Novo Nordisk said late last year that it had tested compounded products allegedly being sold by two Florida pharmacies. It said 33% of one sample was "unknown impurities." Another sample was also impure and contained lower levels of the active ingredient than described, according to a separate lawsuit.
More information
The U.S. Food and Drug Administration has more about compounded drugs.
SOURCE: NBC News
When prescribed a compound medication, ask whether ingredients are approved by the U.S. Food and Drug Administration.