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Novo Nordisk Moves to Restrict Compounded Versions of Ozempic Amid Market Disputes

Novo Nordisk, the pharmaceutical company behind the popular diabetes and weight-loss drugs Ozempic and Wegovy, is actively working to limit compounded versions of these medications in the U.S. The company has petitioned the FDA to add semaglutide, Ozempic’s active ingredient, to the Demonstrably Difficult to Compound (DDC) list. If granted, this designation would bar compounding pharmacies from producing generic-like versions, effectively pushing patients toward FDA-approved products.

Novo Nordisk argues that the complexities involved in compounding semaglutide safely justify their request, citing patient safety concerns as the primary reason. Jamie Bennett, Novo Nordisk’s director of media relations, stressed that compounded versions of semaglutide carry risks of adverse effects due to dosing inconsistencies and quality issues. Although compounded drugs can legally bypass FDA approval when specific criteria are met—such as during drug shortages—the FDA has received reports of side effects associated with compounded semaglutide products.

The backdrop of this move is a broader tension between pharmaceutical companies and the compounding industry, particularly as telehealth providers capitalize on the high demand for GLP-1 drugs like Ozempic. Telehealth clinics and pharmacies often offer compounded versions at a fraction of the price, sometimes as low as $100 monthly compared to the brand-name cost of around $1,000. This market competition has prompted Novo Nordisk to file numerous lawsuits against companies selling compounded alternatives, alleging unfair competition and trademark infringement.

Novo Nordisk is not alone in this push to limit compounded alternatives. Following a similar pattern, Eli Lilly, the producer of tirzepatide (marketed as Mounjaro and Zepbound), also took action recently when the FDA initially declared a resolution to the drug’s shortage, leading to a halt in compounded tirzepatide production. However, this decision was met with resistance, and the FDA is now reassessing tirzepatide’s shortage status, allowing limited compounding to resume.

With semaglutide still listed as in shortage, the compounding industry continues to offer compounded alternatives. However, should this shortage end, compounding pharmacies may find themselves barred from producing these high-demand drugs, heightening the battle between brand-name pharmaceutical giants and independent compounding businesses.

Call for Reform: Cyprus Faces New Challenges with Emerging Tobacco Products

In the face of a burgeoning variety of tobacco products, existing smoking laws in Cyprus are struggling to keep pace, as highlighted by Christos Minas, the president of the Cyprus National Addictions Authority (AAEK). On World No-Tobacco Day, there was a push for legislative reforms to comprehensively cover all tobacco forms, including non-nicotine alternatives.

Addressing Rising Trends with Effective Policies

Minas emphasized the surge in popularity of e-cigarettes and flavored products, particularly among the youth. The proposed legal updates aim to enhance enforcement efficiency against these emerging trends.

In collaboration with the World Health Organization’s (WHO) framework, the AAEK has established the first set of national guidelines for smoking cessation in Cyprus, crafting prevention and treatment strategies based on robust scientific evidence.

Educating Youth and Public Awareness Initiatives

Efforts are underway to raise awareness, with informative materials distributed to secondary schools across Cyprus. A public event in Nicosia highlighted the state’s ongoing commitment, providing carbon monoxide testing and expert advice on new tobacco products.

Recent data from the Cyprus general population survey 2023 indicates that 38% of smokers have used e-cigarettes recently, and the smoking initiation age remains at 18.

A Glimpse into Youth Smoking Patterns

According to the latest European school survey, 14% of Cypriot students aged 15-16 reported smoking traditional cigarettes last month. Although this rate is declining, Cyprus still ranks high in Europe for e-cigarette and hookah use among students.

The concern is global, with WHO reports showing over 37 million children aged 13-15 engage in tobacco use, driven by aggressive marketing in loosely regulated environments.

The urgency for reform is clear: before these trends solidify, proactive measures are necessary to protect future generations from potentially hazardous habits.

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