Latest news with #SteveBenz
Business Mayor
28-04-2025
- Business
- Business Mayor
Novo Nordisk scores major legal win that bars many compounded versions of Wegovy, Ozempic
Flags with the logos of Danish drugmaker Novo Nordisk, maker of the blockbuster diabetes and weight-loss treatments Ozempic and Wegovy are pictures while the company presents the annual report at Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025. Mads Claus Rasmussen | Afp | Getty Images Novo Nordisk scored a huge legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker's blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. A federal judge in Texas late Thursday rejected a bid by compounding pharmacies to keep making copies of Ozempic and Wegovy while a legal challenge over the shortage of those drugs unfolds. That came in response to a February lawsuit from a compounding trade group against the Food and Drug Administration's determination that the active ingredient in those drugs, semaglutide, is no longer in shortage in the U.S. Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn't have insurance coverage for the costly treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. Many telehealth companies, such as Hims & Hers , also offered those copycats. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient's needs. 'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage' of semaglutide is resolved, said Steve Benz, Novo Nordisk's corporate vice president, legal and U.S. general counsel, in a statement. '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,' he said, referring to the company's more than 100 lawsuits against compounding pharmacies and other entities across 32 states. On Thursday, U.S. District Judge Mark Pittman specifically denied the Outsourcing Facilities Association's bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide. That decision upholds the FDA's previous determination that the semaglutide shortage in the U.S. is over and means the FDA can now immediately go after so-called 503A pharmacies that are making compounded versions of semaglutide according to individual prescriptions for a specific patient. Those pharmacies are largely regulated by states rather than the FDA. The decision also means the FDA can start targeting federally regulated 503B pharmacies, which manufacture compounded drugs in bulk with or without prescriptions, after May 22. The agency's actions can include product seizures and warning letters to pharmacies.
Malaysian Reserve
26-04-2025
- Business
- Malaysian Reserve
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 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 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
Epoch Times
25-04-2025
- Business
- Epoch Times
Court Ruling Limits Ozempic Copies in Favor of FDA, Novo Nordisk
A federal court in Texas has The ruling, issued April 24 in the U.S. District Court for the Northern District of Texas, denied a request from the Outsourcing Facilities Association (OFA) to block the FDA's recent That decision effectively ended a temporary allowance for pharmacies to compound semaglutide-based drugs for patients. Semaglutide is the active ingredient in Ozempic and Wegovy. Court documents remain According to a KFF Without the shortage designation, pharmacies may no longer produce compounded versions of semaglutide except in rare circumstances. Smaller 503A pharmacies must stop immediately, while larger outsourcing facilities have until May 22 before facing FDA enforcement. The FDA said in had been in shortage since 2022 due to 'increased demand.' Related Stories 2/24/2025 1/29/2025 Several other lawsuits regarding another popular weight loss medication called tirzepatide [brand name Zepbound and Mounjaro] are also ongoing, as its manufacturer, Eli Lilly, has taken a similar legal approach as Novo Nordisk. The FDA In an emailed statement to The Epoch Times on Friday, the Outsourcing Facilities Association said it was 'deeply disappointed' by the court's decision. 'The U.S. District Court for the Northern District of Texas misapprehended or failed to take into consideration the clear and convincing evidence that demonstrates that the manufactured supply of semaglutide is not able to meet the enormous demand in the U.S.,' said OFA Chairman Lee H. Rosebush. 'We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA. We will not stop in our efforts to ensure that patients can get access to this vital medication.' Novo Nordisk said the ruling supports the FDA's conclusion that the supply of its brand-name semaglutide products is sufficient to meet U.S. demand. '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,' the company said in the statement. 'With the FDA's resolution of the shortage of Ozempic® and Wegovy®, as left in place by this court ruling, it is illegal under U.S. compounding laws to make or sell knockoff 'semaglutide drugs,' with rare exceptions.' The company said it has filed 111 lawsuits in federal courts across 32 states to stop the marketing and sale of what it describes as knockoff or misbranded compounded versions. '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, Novo Nordisk's general counsel. '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.' While brand-name drugs such as Ozempic and Wegovy can cost Novo Nordisk says its legal efforts are aimed at protecting patients from unsafe or unregulated products, including those made with synthetic semaglutide from overseas suppliers, such as manufacturers in China that have not been reviewed by the FDA. Novo Nordisk and the FDA did not respond to additional questions from The Epoch Times before publication time.
Yahoo
25-04-2025
- Business
- Yahoo
Copycat Ozempic makers just lost a big court fight
A federal judge in Texas handed Novo Nordisk (NVO) a big win late Thursday in its battle against cheaper versions of its blockbuster drugs Ozempic and Wegovy, rejecting a bid by compounding pharmacies to keep making the drugs while a legal challenge moves forward. In a sealed order U.S. Judge Mark Pittman denied a request for preliminary injunction a trade group representing compounding pharmacies that would have prevented the Food and Drug Administration from taking action against its members for making knock-off versions using semaglutide, the active ingredient in the weight loss drugs. Small-scale compounders must now immediately stop making their versions of Ozempic and Wegovy. Larger, federally licensed compounders have until May 22 to keep producing the copycats. The popular drugs had been in short supply for some two years, which led the FDA to declare a shortage, thus allowing pharmacists to legally make compounded versions of the patented medications. Many telehealth companies also jumped into the market with compounded drugs. However, in February the FDA determined that the semaglutide shortage was over, leading to the lawsuit by Outsourcing Facilities Association. '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 U.S. General Counsel, Novo Nordisk in an statement. He said that the company will continue driving legal actions forward 'and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.' Compounding pharmacies make drugs tailored to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA. Eli Lilly (LLY) has also taken aggressive legal action against compounding pharmacies, and on Wednesday filed lawsuits against four telehealth companies that offer cheaper versions of its weight loss drugs Mounjaro and Zepbound. For the latest news, Facebook, Twitter and Instagram.
USA Today
25-04-2025
- Business
- USA Today
Less expensive Ozempic, Wegovy copies restricted after federal court ruling
Less expensive Ozempic, Wegovy copies restricted after federal court ruling Show Caption Hide Caption Ozempic warning: Experts warn of side effects from weight loss drug Experts are warning of the possible side effects of popular diabetes medications such as Ozempic and Mounjaro when used for weight loss. The pharmaceutical company that makes the weight-loss drug Wegovy and the diabetes medication Ozempic secured a court victory that limits compounding pharmacies from selling versions of those popular drugs. A federal judge April 24 rejected a bid by compounding pharmacies to continue selling less expensive copies of semaglutide, Novo Nordisk's blockbuster drug sold under the brands Wegovy and Ozempic. The court ruling closes a legal window that allowed compounding pharmacies to make and sell large quantities of the lucrative weight-loss drugs. Many consumers turned to these less-expensive compounded versions of the weight-loss and diabetes drugs because they said they could not afford the brand medications. The Food and Drug Administration allows compounding pharmacies to sell copies of drugs when the medications are in short supply. In February, the FDA declared the semaglutide shortage over and set deadlines for enforcement action against compounding pharmacies and facilities that essentially copied Novo Nordisk's drug. The FDA said pharmacies or physicians could face enforcement action if they continued to make or dispense compounded semaglutide products beyond April 22. The FDA set a May 22 deadline for facilities that compound, distribute or dispense semaglutide. The industry trade group Outsourcing Facilities Association sued the FDA in U.S. District Court in Texas and sought a preliminary injunction to delay enforcement while the court case proceeded. But U.S. District Judge Mark Pittman on Thursday denied compounders' bid for a preliminary injunction. '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,' Steve Benz, Novo Nordisk's corporate vice president, legal and general counsel, said in a statement. Outsourcing Facilities Association Chairman Lee H. Rosebush said the organization is "deeply disappointed" the court failed to consider "clear and convincing evidence" that existing supply of semaglutide doesn't meet consumers' demand. "We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA," Rosebush said. "We will not stop in our efforts to ensure that patients can get access to this vital medication.' In December, the FDA declared that Eli Lilly's weight loss and diabetes medication tirzepatide, sold under the brand names Mounjaro and Zepbound, was no longer in short supply. The Outsourcing Facilities Association unsuccessfully sought a preliminary injunction to continue marketing compounded tirzepatide. March 5, a federal judge rejected the request for a preliminary injunction. That means pharmacies and facilities that sell batches of the medication could face FDA enforcement.
