USA — Novo Nordisk, a prominent pharmaceutical company, has recently taken legal action against compounding pharmacies, filing three lawsuits in Florida and one in Tennessee.
The lawsuits accuse these companies of engaging in the illegal marketing and sale of drugs that purportedly contain semaglutide, the active ingredient found in Novo Nordisk’s popular treatments such as Wegovy, Ozempic, and Rybelsus.
This move comes shortly after the initial round of five lawsuits filed by Novo Nordisk just two weeks ago, further demonstrating the company’s commitment to combating the illicit production of semaglutide compounds.
Following the first round of legal action, Novo Nordisk released a statement asserting, “The practice of selling compounded semaglutide medicines under Novo Nordisk trade names is unlawful and will not be tolerated.”
The company now seeks injunctive relief to prevent these compounding pharmacies from selling unapproved drugs, as well as undisclosed damages.
Currently, Novo Nordisk is the sole company with FDA-approved drugs containing semaglutide, which is the primary ingredient in their highly successful diabetes and weight loss products—Wegovy, Ozempic, and Rybelsus.
The lawsuits specifically target DCA Pharmacy in Tennessee, as well as TruLife Pharmacy, Brooksville Pharmaceuticals, and WellHealth in Florida.
According to Novo Nordisk, these pharmacies are marketing and selling new drugs without obtaining FDA approval, effectively competing with the company’s authorized products in violation of federal and state laws.
The lawsuits argue that bypassing the FDA approval process provides the compounding pharmacies with an unfair competitive advantage while endangering patients by exposing them to potentially unsafe and ineffective drugs.
One of the complaints filed by Novo Nordisk emphasizes the risks associated with unapproved drugs, stating, “When companies circumvent the drug-approval process, safety and efficacy are, at best, unknown.
“The danger is not merely theoretical, as manufacturing and distribution of unapproved new drugs of unknown quality has endangered or adversely impacted public health.”
Compounding drugs typically occur in pharmacies where customized medications are made for individual patients, but these drugs lack FDA approval.
While the FDA acknowledges the importance of compounding drugs for patients requiring specific formulations, such as liquid forms or dye-free alternatives, there are inherent dangers associated with their use.
Wegovy, which is FDA-approved for weight loss, and Ozempic and Rybelsus, both approved for diabetes treatment, have experienced high demand, leading to supply issues for Novo Nordisk.
The company has recently imposed restrictions on starter doses of Wegovy due to supply constraints.
Similarly, the popularity of Ozempic among non-diabetic patients seeking weight loss has also caused supply shortages.
Consequently, Novo Nordisk has revised its revenue forecast for the year, anticipating growth between 24% and 30%, compared to the previously expected range of 13% to 19%.
These Florida lawsuits follow Novo Nordisk’s recent legal action against certain US medical spas and wellness clinics aimed at safeguarding consumers from the “unlawful marketing and sales of non-FDA approved counterfeit and compounded semaglutide products,” as stated by the company.
The FDA issued public guidance in May, cautioning against the safety risks associated with unauthorized versions of Novo Nordisk’s weight-loss drugs following reports of adverse health reactions linked to custom-made variants.
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