News
Press release
Tue, 20 Jun 2023 11:00:00 -0400
Tue, 20 Jun 2023 11:00:00 -0400
Novo Nordisk takes actions to help protect US patients from unlawful sales of non-FDA approved medicines claiming to contain semaglutide
- Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and desist from false advertising, trademark infringement and unlawful sales
- Informing the public on how to identify Novo Nordisk's authentic semaglutide injectable products in the US
- Providing semaglutide.com as resource hub and credible source of information in line with Company's commitment to responsible use of our medicines and patient safety
PLAINSBORO, N.J., June 20, 2023 /PRNewswire/ -- Novo Nordisk announced today that it is taking multiple actions to protect US patients from the unlawful marketing and sales of non-FDA approved counterfeit and compounded semaglutide products claiming to contain semaglutide, while reinforcing the responsible use of Novo Nordisk's FDA-approved medicines. Novo Nordisk's prescription-only, FDA-approved semaglutide medicines are Wegovy® for chronic weight management and Ozempic® and Rybelsus® for type 2 diabetes.
Novo Nordisk has commenced the filing of legal actions in the US against certain medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide. These unlawful marketing and sales practices, including the use of Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception as well as potential safety concerns.
Compounded products do not have the same safety, quality and effectiveness assurances as our FDA-approved drugs and may expose patients to health risks. Novo Nordisk cannot validate the safety or effectiveness of products claiming to contain semaglutide that are not one of our own branded products. Further, the practice of selling compounded semaglutide medicines under Novo Nordisk trade names is unlawful and will not be tolerated. Novo Nordisk is the only company in the US 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. "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 FDA recently also issued guidance on medications containing semaglutide that are marketed for Type 2 diabetes or weight loss, which provides the following:
- "Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs."
- "FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality."
Novo Nordisk has launched semaglutide.com to serve as a credible resource hub for US audiences, including patients, healthcare providers and retailers, to provide information about the responsible use of Novo Nordisk's FDA-approved semaglutide products, the differences between our FDA-approved products and other medicines being labeled as "semaglutide", as well as tools on how to spot a counterfeit injectable product.
Patients prescribed FDA-approved semaglutide injectable products, marketed under the brand names Ozempic® and Wegovy®, should be vigilant in checking their medicine to ensure they are taking an authentic, Novo Nordisk produced version of the authorized drug and injection device. The company urges these patients to only purchase FDA-approved semaglutide medicines from entities authorized to sell these products by the US FDA.
In addition to launching semaglutide.com as a resource hub to the public, Novo Nordisk has disseminated information directly to healthcare providers and is working with other stakeholders to ensure patients are aware of the dangers of compounded or counterfeit products claiming to contain semaglutide. For information on how to identify authentic semaglutide injectable products, please see the company statement here.
About Ozempic®
Ozempic® (semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.
About Rybelsus
Rybelsus® (semaglutide) tablets 7 mg or 14 mg is an analog of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). Rybelsus® is the first and only GLP-1 receptor agonist (RA) in a pill. It is taken once daily and is approved for use in two therapeutic doses: 7 mg and 14 mg.
About Wegovy®
WEGOVY® (semaglutide) injection 2.4 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated for chronic weight management in adults and adolescents aged ≥12 years with obesity (BMI ≥30 for adults, BMI ≥ 95th percentile for age and sex for adolescents), or some adults with excess weight (BMI ≥27) (overweight) who also have weight-related medical problems. Wegovy® should be used with a reduced calorie meal plan and increased physical activity.
Ozempic® is a registered trademark of Novo Nordisk A/S.
Wegovy® is a registered trademark of Novo Nordisk A/S.
Rybelsus® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
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SOURCE Novo Nordisk