Danish pharmaceutical company Novo Nordisk is pursuing legal action against two U.S.-based pharmacies for allegedly selling products claiming to contain semaglutide that are not approved by the U.S. Food and Drug Administration (FDA).
In a statement on Nov. 30, the drugmaker said it had conducted tests on compounded products allegedly sold by Wells Pharmacy and Brooksville Pharmaceuticals, two compounding pharmacies based in Florida.
The company indicated test results revealed the drugs were “adulterated and misbranded injectable compounded drugs” that claim to contain semaglutide—which is the main ingredient used in Novo Nordisk’s in-demand weight-loss drugs Wegovy and Ozempic.
Wegovy and Ozempic are actually prescription medications used to treat type 2 diabetes. However, the drugs have become increasingly popular over the last few years due to their weight loss effect.
“Compounded products do not have the same safety, quality and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks,” said Jason Brett, executive director of Medical Affairs at Novo Nordisk.
“Following several analyses of compounded drugs claiming to contain semaglutide, we have seen concerning levels of unknown impurities … which could potentially put patient’s health at risk,” he added.
Both cases were filed in Florida on Nov. 29, although Novo Nordisk first sued Brooksville Pharmaceuticals in July before refiling the lawsuit this week.
Novo Nordisk also said that some samples tested from the compounded versions of Wegovy from Brooksville Pharmaceuticals were less potent than advertised, with one sample showing at least 19 percent less semaglutide than labeled.
Some samples the drugmaker tested from Wells Pharmacy allegedly contained “unknown impurities”—some by as much as 33 percent—which Novo Nordisk warned may pose safety risks to patients. Other samples contained the peptide BPC-157, which the FDA announced in September 2023 cannot be used in compounded drugs due to safety concerns.
Additionally, Novo Nordisk is also trying to stop Wells Pharmacy from allegedly using “false and misleading statements” claiming its compounded drug has been approved by the FDA, as well as that its product “has been subjected to the same clinical studies and trials as Novo Nordisk’s FDA-approved semaglutide medicines.”
Brooksville Pharmaceuticals managing partner Terry Myers, meanwhile, disputed the new lawsuit in a statement, noting the company plans to file another motion to dismiss.
“We purchase all of our bulk ingredients, including semaglutide, from FDA-registered facilities,” Brooksville Pharmaceuticals told Fox Business. “We have also tested our semaglutide formulation with a third party lab and found it to remain potent for 180 days when stored in a refrigerator, 90 days when stored at room temperature and 45 days when stored at 40 degrees Celsius.”
The Florida-based company also argued that state-licensed compounding pharmacies play a “critical role in providing thousands of patients across the United States with an essential medication.”
Wells Pharmacy did not respond to a request for comment by press time.
Novo Nordisk has already filed 12 lawsuits against medical spas, weight-loss clinics, and compounding pharmacies offering products that claim to contain semaglutide.
The company said it had obtained temporary orders against six of those to stop them from claiming their products are authentic, FDA-approved, or associated with Novo Nordisk.
Novo Nordisk’s biggest rival in the obesity drug market, U.S.-based pharmaceutical giant Eli Lilly, has also sued multiple medical spas, wellness centers, and compounding pharmacies across the United States in September in an effort to stop them from selling products purporting to contain tirzepatide, the active ingredient in its diabetes drug Mounjaro and recently-approved weight loss medicine Zepbound.
Reuters contributed to this report.
