Ozempic Maker Sues Over Off-Brand Versions of Popular Weight-Loss Drugs
The FDA recently warned consumers that the knock-offs likely contain a version of the active ingredient that is not approved for use in humans
The company that makes Ozempic and Wegovy has filed multiple lawsuits over non-approved copies of the drugs that have become popular for weight loss.
Novo Nordisk says it is going after the unlawful marketing and sales of counterfeit versions of the medicines sold at medical spas, weight loss clinics and compounding pharmacies.
The suits seek to “cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.”
Semaglutide is the active ingredient in the brand-name medications.
In a news release, the Danish drugmaker says the counterfeits have created a high risk of consumer confusion and deception as well as potential safety concerns.
Novo Nordisk is the only company in the U.S. with FDA-approved products containing semaglutide, and no FDA-approved generic versions of semaglutide currently exist.
"Our priority is to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines, and these actions are a direct reflection of that focus," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk.
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“We believe it's important to provide additional tools and education to support the proper use of our approved semaglutide products and create broad public awareness regarding the difference between our FDA-approved medicines and other products being labeled as semaglutide."
The U.S. Food and Drug Administration recently warned consumers about off-brand versions of Ozempic and Wegovy.
Regulators warn they might not contain the same ingredients as the prescription products and may not be safe.
The off-brand versions, often sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in humans, according to the FDA.
The FDA received reports of "adverse events" after patients used knock-off versions of semaglutide but didn’t elaborate on what the problems were.
“Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the notice said.
Sales of semaglutide products have soared in the past few years after the drug was shown to spur fast and significant weight loss.
Demand for the medications has outstripped supply. As of May, Ozempic and Wegovy remain on the FDA’s list of drug shortages.
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