logo
Novo Nordisk protects US patients with legal wins against compounders, including ruling that permanently prohibits compounding pharmacy from selling illegitimate, knockoff Wegovy® or Ozempic®

Novo Nordisk protects US patients with legal wins against compounders, including ruling that permanently prohibits compounding pharmacy from selling illegitimate, knockoff Wegovy® or Ozempic®

Federal court ruling leaves in place FDA's decision resolving the shortage of Wegovy® and Ozempic®, which are fully available nationwide, and ends the grace period for pharmacies to make or sell compounded 'versions' of these medicines
Separate federal court ruling permanently bars MediOak Pharmacy LLC from marketing or selling illegitimate 'semaglutide' drugs
Legal wins build on 111 lawsuits filed by Novo Nordisk across 32 states against entities unlawfully marketing and selling compounded 'semaglutide' drugs, helping safeguard Americans from knockoffs made with unsafe or illicit foreign API
Novo Nordisk is dedicated to dialogue with companies to support patient access to authentic, FDA-approved Wegovy® under the care of a licensed healthcare professional
PLAINSBORO, N.J., April 25, 2025 /PRNewswire/ — Yesterday, a Texas federal court ruled in favor of Novo Nordisk and FDA, denying a compounding trade association's motion to freeze the FDA's decision to end the shortage of semaglutide injectable medicines. The court's ruling left in place FDA's prior determination that all doses of Wegovy® and Ozempic® are fully available nationwide and that Novo Nordisk's supply of these FDA-approved medicines is meeting or exceeding current and projected nationwide patient demand. With the FDA's resolution of the shortage of Ozempic® and Wegovy®, as left in place by this court ruling, it is illegal under US compounding laws to make or sell knockoff 'semaglutide drugs,' with rare exceptions.
In light of the court's decision today, FDA may immediately take action against 503A pharmacies compounding knockoff versions of Novo Nordisk's FDA-approved semaglutide medicines. The ruling also means the grace period for 503B outsourcing facilities to compound semaglutide injectable drugs will expire on May 22, 2025, and FDA may take enforcement action against these entities after that date.
This latest win on behalf of patients follows another key decision by the District Court for the Southern District of Texas, where a federal judge entered a final judgment and permanent injunction in favor of Novo Nordisk, against a 503A pharmacy, MediOak Pharmacy LLC, permanently prohibiting them from marketing or selling compounded 'semaglutide' knockoff drugs.
'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy® and Ozempic® is resolved,' said Steve Benz, Corporate Vice President, Legal and US General Counsel, Novo Nordisk. 'FDA's determination was based on a thorough review of Novo Nordisk's stable and growing supply of these important FDA-approved medicines. With the end of the shortage of Wegovy® and Ozempic®, no patient should have to be exposed to unsafe, inauthentic 'semaglutide' drugs. Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate 'semaglutide' drugs are working. We will continue driving these actions forward and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.'
Illicit foreign API in compounded 'semaglutide'
The resolution of the semaglutide injection shortage and the court's ruling also help protect patients against the proliferation of unsafe and unlawful drugs compounded using imports of synthetic 'semaglutide' active pharmaceutical ingredients (APIs) that are manufactured overseas. A recently published Brookings Institute report titled The Wild East of semaglutide confirms that many US patients are being exposed to unsafe and illegal imports of synthetic semaglutide APIs from China. The report highlights numerous issues, including that manufacturers of chemically synthesized semaglutide API have no external reference standard for quality and instead determine specifications themselves. It also demonstrated that three Chinese firms are responsible for 20% of the reported quantity of semaglutide imported into the US between March 2023 and September 2024 and have never been inspected by FDA, as of September 2024. Additionally, another three Chinese firms, responsible for nearly 45% of reported imported volume during this 18-month period, were cited during their latest FDA inspection for current good manufacturing practice violations. As this report shows, the quality of API originating from China and used in compounded 'semaglutide' in the US cannot be assured and puts patients at serious risk. Novo Nordisk does not directly or indirectly distribute the semaglutide API in its FDA-approved medicines to any entity for use in compounding.
Novo Nordisk federal lawsuits filed to date
To date, the company has filed 111 lawsuits in federal courts across 32 states against entities unlawfully marketing and selling compounded 'semaglutide,' including drugs that pose significant risks to patient safety due to high levels of impurities (as high as 33%) or misbranded due to inaccurately labeled strengths.
Many of these courts have already issued injunctions permanently prohibiting these entities from the unlawful marketing and sales of compounded drugs:
Earlier this year, a federal court in Delaware entered an $8.5 million default judgment in Novo Nordisk's favor against a business for willfully and falsely claiming that their compounded 'semaglutide' drugs were equivalent to Ozempic® or used the same active ingredient as FDA-approved Ozempic®. Another federal court permanently prohibited a compounding pharmacy in Tennessee, Midtown Express, from marketing or selling knockoff 'semaglutide' after Novo Nordisk sued it for selling a drug that contained no semaglutide at all.
In another case, a federal court granted a default judgement against an online marketer sued by Novo Nordisk, ending its unlawful practice of selling compounded 'semaglutide' directly to consumers without a prescription or instructions for use, misleadingly labeling it as for 'Research Use Only.'
Dozens of other courts have entered permanent injunctions against the entities sued by Novo Nordisk, permanently forbidding them from falsely claiming that knockoff 'semaglutide' drugs: (1) are genuine Novo Nordisk medicines; (2) are approved by FDA, are authentic generic medicines, or are safe and effective; (3) achieve any therapeutic result or are safe or effective based on the clinical trial results for Novo Nordisk's approved medicines; and (4) contain semaglutide that has been approved by FDA, is supplied by Novo Nordisk, or is the same as that in Wegovy® and Ozempic®.
The court orders also direct businesses to correct misimpressions among patients that were caused by the defendants' deceptive practices. This includes posting prominent disclosures in marketing and advertising to make clear that the unapproved compounded drugs have not been reviewed or approved by the FDA, that the manufacturing processes used to make the drugs are not FDA-reviewed, and that actual FDA-approved semaglutide medicines are available.
Actions taken by third parties to warn the public
Novo Nordisk supports the actions that have already been taken by law enforcement to protect patients from illegal marketing and sales of compounded drugs. A bipartisan coalition of 38 state Attorneys General have called on the FDA to take swift action against compounding pharmacies that 'cut corners in pursuit of a quick profit' and sell knockoff drugs that could lead to 'serious public health issues.' The Ohio Attorney General recently issued a press release about letters it sent to 14 entities warning them to stop deceiving patients into believing that compounded drugs are approved by the FDA or have been reviewed for safety, effectiveness, or quality and declaring that patients 'deserve clear and accurate information about the medication they're putting in their bodies.' Similarly, in December 2024, the Illinois Attorney General issued cease-and-desist letters to five Chicagoland med spas advertising name brand medications like Wegovy® and Ozempic® but 'instead offering unapproved versions of these products that may put people's health at risk.' In addition, over a dozen Attorneys General have issued statements discussing the dangers posed by knockoff 'semaglutide,' including North Carolina, South Carolina, and Tennessee.
The Federal Bureau of Investigation also recently warned the public about safety concerns related to fraudulent compounding practices associated with weight loss drugs, warning that '[s]ome healthcare providers are using compounded mixtures of unknown drugs that do not contain semaglutide, drugs with high levels of impurities, and unsafe or unapproved drugs.'
Novo Nordisk is continuing to actively address this issue through education, advocacy, and legal action, fighting on behalf of patients who deserve to know what they are injecting into their body.
For more information about Novo Nordisk's efforts to protect patients and ensure access to safe, effective FDA-approved treatments, visit semaglutide.com
About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Deal ‘is done', says Trump, as China and US trade truce gets back on track after London talks
Deal ‘is done', says Trump, as China and US trade truce gets back on track after London talks

The Star

time2 hours ago

  • The Star

Deal ‘is done', says Trump, as China and US trade truce gets back on track after London talks

BEIJING: China and the United States agreed to revive a fragile trade truce after two days of talks in London, further defusing tensions between the two geopolitical rivals. US President Donald Trump said on Wednesday (June 11) that the deal with China 'is done' and that the relationship was 'excellent'. Hours earlier, Chinese Vice-Premier He Lifeng, who led the negotiating delegation in London, called on the US to 'stay true to your words', and 'demonstrate good faith in keeping promises'. The agreement, which concluded close to midnight on June 10 in London, followed a roller coaster of rising and easing tensions over non-tariff measures, after both sides agreed in May in Geneva to a 90-day truce that sharply lowered tariffs on each other's goods. The main sticking points since May were Beijing's restrictions on rare earth exports to the US and Washington's curbs on the export of chip design technology to China. In a Truth Social post, Trump said full magnets, along with any necessary rare earth minerals, will be supplied upfront by China. In return, the US will provide to China 'what was agreed to', including allowing Chinese students to attend colleges and universities in the US, which he noted 'has always been good with me!'. Separately, US Commerce Secretary Howard Lutnick told reporters that the 'framework' reached in London puts 'meat on the bones' of the Geneva agreement, adding that it will still need approval from both leaders. He said Chinese restrictions on rare earth minerals and magnets and some of the recent US export restrictions would be removed 'in a balanced way' but did not provide details. China's Vice-Commerce Minister Li Chenggang told reporters after the talks that both countries had agreed on a framework to implement the consensus that Chinese President Xi Jinping and Trump had reached after a June 5 phone call, as well as May's trade truce. He described the talks as in-depth, professional, rational and frank. 'The progress achieved at the London talks is beneficial to enhancing trust between the two countries, advancing the healthy and stable development of China-US economic ties, as well as provide positive energy to the global economic development,' Li said. Analysts saw the latest talks as positive. Professor Wu Xinbo, director of the Centre for American Studies at Shanghai's Fudan University, said he expects the US to roll back the non-tariff measures threatened or imposed on China after the Geneva talks, such as revoking visas of Chinese students studying in the US. 'As for the Chinese side, it may accelerate the process of rare earth exports to help resolve the urgent needs of the Americans,' he said. The May agreement was derailed on June 1 when the US accused China of 'slow-rolling' licences for exports of rare earths, which are critical in the production of cars, chips and other products. China dominates the world's rare earth supply chain, accounting for nearly 70 per cent of the global mining output and processing about 90 per cent of the total supply – a trump card Beijing has cultivated for decades. However, economist Bert Hofman noted that China's delay in rare earth export licences was partly due to 'bureaucratic inertia'. 'The process was cumbersome and brought issues for industries around the world, not just for the US. So it was not specifically targeted at US companies,' he said. Washington, meanwhile, activated its own levers on China. On May 29, it announced the revocation of visas for Chinese students and issued export control guidelines for AI chips, as well as effectively halting sales of chip design software to China. Chinese tech firms that design chips rely on such foreign software, known as electronic design automation. China's Ministry of Commerce on June 2 criticised these measures as discriminatory and accused the US of violating the consensus of the Geneva talks. Just as all the signs pointed to the breakdown of the truce, the June 5 call between Xi and Trump was widely seen as having reset fraught relations. This was followed on June 7 by China's Ministry of Commerce's announcement that it had approved a number of applications for rare earth exports, and will continue to strengthen the approval process for such applications. Even as the London talks were ongoing, Beijing strategically underscored its resilience. In a front-page interview on the official People's Daily on June 10, Huawei founder Ren Zhengfei discussed China's technology and research capabilities, particularly in chips. The Chinese telecommunications equipment giant has emerged as a national champion for areas such as AI chips called the Ascend processors, which Washington has recently warned other countries against using. Asked how he feels about Huawei being under a blockade, Ren said: 'Don't think about the difficulties – just do it, one step at a time.' - The Straits Times/ANN

Kelley Blue Book, Experian Team Up to Bring Buyers Better Vehicle History Reports
Kelley Blue Book, Experian Team Up to Bring Buyers Better Vehicle History Reports

Malaysian Reserve

time17 hours ago

  • Malaysian Reserve

Kelley Blue Book, Experian Team Up to Bring Buyers Better Vehicle History Reports

Unmatched Trust and Transparency from Detailed Reports to Boost Buyer Confidence and Drive More Conversions ATLANTA and COSTA MESA, Calif., June 10, 2025 /PRNewswire/ — As the market heats up, along with the competition, it has never been more important to make smart car buying choices based on trusted research. As part of its commitment to drive stronger results for our clients, Kelley Blue Book and Autotrader, Cox Automotive brands, today announced they are expanding their strategic relationship with Experian, a global data and technology company, to co-brand its AutoCheck® vehicle history reports on and vehicle listings. Experian's AutoCheck vehicle history reports offered by Kelley Blue Book combine the power of the storied and trusted Kelley Blue Book brand with the detailed insights Experian already delivers to car buyers and sellers for more efficient decision-making. Experian's AutoCheck vehicle history reports will be available on all eligible listings on both Kelley Blue Book and Autotrader, allowing dealerships to provide potential buyers with detailed vehicle history information and inherent trust in their product. Featured on the vehicle history reports, the proprietary AutoCheck Score offers a quick, clear snapshot of a vehicle's predicted reliability, helping buyers and sellers feel confident every step of the way. 'With proprietary auction data and backed by Kelley Blue Book, the No. 1 trusted automotive brand for shoppers planning to buy in the next six months, dealerships can gain the edge they need to better buy and sell inventory,' said Jessica Stafford, senior vice president, consumer solutions, at Cox Automotive. 'Our clients and consumers will have detailed information to make informed car-buying decisions which, given the current market, is more important than ever before. Increased transparency leads to more confident and informed shopper decisions, and ultimately, more leads for dealers.' Dealerships also benefit from more engagement in listings, reporting with an extensive database of automotive records, and easy-to-understand insights to better compare a vehicle to other similar models currently on the market. In fact, free Experian vehicle history reports drive 44% more lead conversions on Autotrader vehicle detail pages than the leading competitor. * 'Researching and comparing vehicle listings is a critical step in the used car buying experience. Nearly every in-market shopper scours every ounce of information available to help them choose the right vehicle,' said Robert Granados, president of Experian Automotive. 'By joining forces with Kelley Blue Book, we're able to put information about a vehicle's history directly into the hands of more consumers. Now, in-market shoppers will have more transparency when buying a vehicle and feel more confident in their choice.' For more information about Experian AutoCheck offered by Kelley Blue Book, contact your Kelley Blue Book or Autotrader sales representative. *Based on internal analysis of vehicle history report leads submitted from Autotrader listings/VDPs from Dec 2024 – May 2025. Individual results may vary. About Kelley Blue Book Founded in 1926, Kelley Blue Book, The Trusted Resource®, is the vehicle valuation and information source trusted and relied upon by both consumers and the automotive industry for nearly a century. As the industry standard for generations, Kelley Blue Book provides transparent, objective information and data-driven, innovative tools for consumers, automotive dealers and manufacturers. Kelley Blue Book publishes millions of market-reflective values weekly on its top-rated website from its famous Blue Book® Trade-In Values to the Kelley Blue Book® Price Advisor tool, which offers a range for what consumers reasonably can expect to pay for a vehicle in their area. editors rate and review hundreds of new vehicles each year to help consumers understand the Best Cars and Best SUVs to meet their needs. Kelley Blue BookSM Instant Cash Offer provides a redeemable trade-in offer to transaction-ready consumers and conveniently connects them to local participating dealers. Kelley Blue Book's Service Advisor provides guidance on how much to pay for service and repairs, allowing consumers to schedule service with local dealers on Kelley Blue Book also provides vehicle values to finance and insurance companies as well as governmental agencies. Kelley Blue Book is a Cox Automotive brand. About Cox AutomotiveCox Automotive is the world's largest automotive services and technology provider. Fueled by the largest breadth of first-party data fed by 2.3 billion online interactions a year, Cox Automotive tailors leading solutions for car shoppers, auto manufacturers, dealers, lenders and fleets. The company has 29,000+ employees on five continents and a portfolio of industry-leading brands that include Autotrader®, Kelley Blue Book®, Manheim®, vAuto®, Dealertrack®, NextGear Capital™, CentralDispatch® and FleetNet America®. Cox Automotive is a subsidiary of Cox Enterprises Inc., a privately owned, Atlanta-based company with $23 billion in annual revenue. Visit or connect via @CoxAutomotive on X, CoxAutoInc on Facebook or Cox-Automotive-Inc on LinkedIn. About ExperianExperian is a global data and technology company, powering opportunities for people and businesses around the world. We help to redefine lending practices, uncover and prevent fraud, simplify healthcare, deliver digital marketing solutions, and gain deeper insights into the automotive market, all using our unique combination of data, analytics and software. We also assist millions of people to realise their financial goals and help them to save time and money. We operate across a range of markets, from financial services to healthcare, automotive, agrifinance, insurance, and many more industry segments. We invest in talented people and new advanced technologies to unlock the power of data and to innovate. A FTSE 100 Index company listed on the London Stock Exchange (EXPN), we have a team of 23,300 people across 32 countries. Our corporate headquarters are in Dublin, Ireland. Learn more at

Applied Medical Technology, Inc. Unveils Redesigned Mobile App Aligned with Recent Website Refresh
Applied Medical Technology, Inc. Unveils Redesigned Mobile App Aligned with Recent Website Refresh

Malaysian Reserve

timea day ago

  • Malaysian Reserve

Applied Medical Technology, Inc. Unveils Redesigned Mobile App Aligned with Recent Website Refresh

BRECKSVILLE, Ohio., June 10, 2025 /PRNewswire/ — Applied Medical Technology, Inc. (AMT), a leader in innovative medical devices, is proud to announce the launch of its redesigned mobile application, AMT ONE Source®. This strategic update follows a successful website redesign completed late 2024, ensuring that both platforms now offer a cohesive, user-friendly digital experience. Enhancing User Experience Across PlatformsThe redesigned mobile app mirrors the modern, intuitive design language introduced during the website refresh. With a renewed focus on user experience and engagement, the mobile platform now features streamlined interfaces and updated information. 'In today's fast-paced healthcare environment, it is essential that our digital platforms are not only reliable but also easy to navigate and visually appealing,' said Bill Bentley, National Sales Manager. 'Created with our youngest patients in mind, the redesign was thoughtfully developed to be more engaging, age-appropriate, and easy to navigate—helping children and their families feel more supported and empowered throughout their healthcare journey.' Key Features and Benefits Unified Design Aesthetic: The mobile app adopts the clean, modern design previously launched on the website, providing a consistent look and feel across all digital touchpoints. Richer Content Experience: The app now features an expanded content database, providing a broader range of resources and information to support users with timely, relevant, and easy-to-access content. Improved Performance: The redesigned app features enhanced performance, with a new backend architecture that allows for faster content updates, easier maintenance, and more frequent improvements to keep the experience fresh and relevant. AMT partnered with Cleveland-Ohio based software company, Stream 9, on the redesign. Their strong track record in software design and development brought deep technical expertise and a strategic approach. 'We're fortunate in our business to develop custom software projects for businesses of all kinds; but it's especially rewarding to work on a project that will deliver such a direct benefit to patients and their caregivers. AMT brought a clear vision to the table, and we worked closely together to translate that into a modern, scalable, and user-friendly digital experience,' shared Kirk Miesle, Founder of Stream 9. The AMT ONE Source® app is available now on the App Store and Google Play. About AMT: Applied Medical Technology, Inc. (AMT) is a global leader in enteral and surgical devices committed to improving lives through innovation. For 40 years, AMT has bridged the gap between medical technology and patient needs, collaborating with healthcare professionals and users to develop high-quality, life-enhancing solutions. Our holistic approach prioritizes the well-being of the whole person, not just the device they use.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store