Novo Nordisk has filed 14 new lawsuits to protect patients from unsafe and unapproved compounded drugs claiming to contain “semaglutide.” The defendants named in these lawsuits employ tactics that deceive patients into believing that compounded products have been reviewed and approved by the FDA or have equivalent safety or effectiveness as Novo Nordisk’s approved semaglutide medicines. 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). Executive Vice President of US Operations of Novo Nordisk Inc.
said, “Patients deserve safe, effective treatments from companies they can trust. No one should have to risk their health by using knockoff drugs made with ingredients that lack oversight and safety standards.”
Novo Nordisk has filed 132 complaints in federal courts across 40 states to date, targeting companies whose illegal marketing and business practices put patient safety at risk. The new lawsuits 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 and telehealth companies where corporations, not doctors, improperly steer patient care to compounded “semaglutide” drugs using sham claims of personalization, violating state corporate practice of medicine laws.
Filing lawsuits to protect patients
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. The FDA has issued multiple alerts warning patients and healthcare professionals about the dangers of these knockoff drugs, including reports of patients overdosing by mistakenly administering five to 20 times the intended dose and requiring hospitalization.
Independent data underscores the dangers posed by compounded “semaglutide” products, highlighting that many rely on synthetic API imported from facilities that lack FDA oversight or quality controls. Novo Nordisk has launched educational campaigns like “Check Before You Inject” to raise awareness about the risks of unapproved knockoffs. The company also created resources for patients to learn about the dangers of compounded and counterfeit products, as well as how to access authentic, FDA-approved treatments.
Novo Nordisk remains committed to fighting on behalf of patients who deserve to know what they are injecting into their bodies. For more information about these efforts to protect patients and ensure access to safe, effective FDA-approved treatments, visit novonordisk-us.com.