These filings come after FDA issued its latest warning to patients and healthcare professionals about the serious dangers of compounded GLP-1 drugs
Novo Nordisk announced the filing of 14 new lawsuits to safeguard patients from unsafe and unapproved compounded drugs claiming to contain "semaglutide."
The defendants named in these lawsuits employ tactics that deceive patients into believing compounded products have been reviewed and approved by FDA or have equivalent safety or effectiveness as Novo Nordisk's approved semaglutide medicines.
The lawsuits allege that telehealth providers violate state corporate practice of medicine laws by improperly influencing doctors' decisions and steering patients toward knockoff compounded "semaglutide" under the false guise of personalized medicine. In reality, these are unapproved knockoffs that have not been approved as safe and effective and are often made with illicit foreign active pharmaceutical ingredients (API).
"Patients deserve safe, effective treatments from companies they can trust. No one should have to gamble with their health by using knockoff drugs made with ingredients that lack oversight and safety standards," said Dave Moore, Executive Vice President, US Operations of Novo Nordisk.
"Novo Nordisk is addressing this issue through education, advocacy, and legal action against businesses that mislead Americans and jeopardize their health with unsafe and unapproved knockoffs. We urge regulators to enforce laws designed to protect public health."
To date, Novo Nordisk has filed 132 complaints in federal courts across 40 states, targeting companies whose illegal marketing and business practices put patient safety at risk. Today's lawsuits build on Novo Nordisk's earlier litigation successes and expand the focus of its legal actions into two new areas:
* Pharmacies producing unapproved compounded "semaglutide" drugs under the fake guise of personalization in violation of state law.
* Telehealth companies where corporations, not doctors, improperly steer patient care to compounded "semaglutide" drugs using sham claims of personalization, violating California law.
Courts have already issued 44 permanent injunctions against defendants in similar cases, prohibiting them from a variety of unlawful conduct including unlawfully compounding "semaglutide" and falsely claiming that compounded "semaglutide" products are FDA-approved, safe, or equivalent to Novo Nordisk's authentic medicines like Wegovy or Ozempic. Courts have also taken steps to deter similar conduct, including ordering defendants to forfeit illegally obtained profits.
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