
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.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Newsweek
10 minutes ago
- Newsweek
Mushroom Recall Sparks Nationwide Warning to Customers
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Hofood99 Inc. is recalling packages of their Enoki Mushrooms due to fears the product may be contaminated with listeria. Newsweek reached out to the company via phone for additional comment on Wednesday and left a voicemail. Why It Matters Numerous recalls have been initiated this year due to the potential for the following: damaged products, foodborne illness, contamination and undeclared food allergens. Millions of Americans experience food sensitivities or food allergies every year. According to the Food and Drug Administration (FDA), the nine "major" food allergens in the U.S. are eggs, milk, fish, wheat, soybeans, Crustacean shellfish, sesame, tree nuts and peanuts. The FDA warns that Listeria monocytogenes is an organism that could cause serious and sometimes fatal infections in frail or older people, young children and those with weakened immune systems. Listeria could also lead to stillbirths or miscarriages in pregnant women, the FDA says. What To Know According to the FDA alert, the mushrooms were distributed nationwide to stores and retailers. The recalled mushrooms are sold in 200-gram green plastic packaging with a with UPC Barcode of 6 976532 310051 seen on the back label. No illnesses or injuries have been reported related to the recalled mushrooms. The mushrooms were distributed by Hofood99 Inc., located at 21903 56th Avenue Oakland Gardens, New York 11364. Recalled packages of Enoki Mushroom from Hofood99 Inc. can be seen in a June 11, 2025, recall alert. (Photo from the U.S. Food and Drug Administration) Recalled packages of Enoki Mushroom from Hofood99 Inc. can be seen in a June 11, 2025, recall alert. (Photo from the U.S. Food and Drug Administration) What People Are Saying The FDA in the alert in part: "The contamination was discovered after samples were collected from a store in Michigan and subsequent analysis by Michigan Department of Agriculture & Rural Development (MDARD) Laboratory Division revealed the presence of Listeria monocytogenes." In an email to Newsweek in January, the FDA said: "Most recalls in the U.S. are carried out voluntarily by the product manufacturer and when a company issues a public warning, typically via news release, to inform the public of a voluntary product recall, the FDA shares that release on our website as a public service. "The FDA's role during a voluntary, firm-initiated, recall is to review the recall strategy, evaluate the health hazard presented by the product, monitor the recall, and as appropriate alert the public and other companies in the supply chain about the recall," the FDA continued. It added: "The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, including the specific action taken by the recalling company. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled." Additional information on recalls can be found via the FDA's Recalls, Market Withdrawals, & Safety Alerts. What Happens Next Customers who have purchased the recalled mushrooms may return the product to the original place of purchase for a full refund or destroy it, the FDA says. People with additional questions may contact the company at (917) 756-9833 weekdays from 9 a.m. to 2 p.m.


Medscape
2 hours ago
- Medscape
Taletrectinib Approved for NSCLC
The FDA has approved taletrectinib (Ibtrozi, Nuvation Bio) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in first- and later-line settings, regardless of prior ROS1 tyrosine kinase inhibitor (TKI) exposure. Taletrectinib is considered a next-generation ROS1 TKI to distinguish it from two first-generation products already on the US market: crizotinib and entrectinib. A third ROS1 TKI approved in 2023, repotrectinib, is also a next-generation medicine. Like repotrectinib, FDA granted taletrectinib a breakthrough therapy designation. Compared with crizotinib and entrectinib, Nuvation Bio data suggests taletrectinib has greater brain penetration, lower incidence of neurologic adverse events, less likelihood of resistance, and other benefits, plus a possible safety and efficacy edge over next-generation rival repotrectinib. 'Taletrectinib will likely become the preferred treatment option for advanced ROS1+ NSCLC,' commented Thomas E. Stinchcombe, MD, an associate editor at the Journal of Clinical Oncology , in the 'Context' section of his journal's publication of a pooled analysis of Nuvation Bio's two approval studies, TRUST-I and TRUST-II, in April. Taletrectinib was originally developed in China and was approved there in Jan 2025 for the same indication granted by FDA. The company plans a US launch in mid-2025, they stated in a press release. About 2% of NSCLC patients have ROS1-positive disease, and about a third of them present with brain metastases. ROS1-positive patients have an oncogenic rearrangement in the ROS1 gene, which leads to an abnormal ROS1 fusion protein that drives cancer growth. ROS1 TKIs block the protein's activity. The drug's approval was based on results of TRUST-I and TRUST-II, phase 2, single-arm, open label studies in ROS1-positive NSCLC patients treated with oral taletrectinib 600 mg once daily until progression, unacceptable toxicity, death, or consent withdrawal. Of the 273 subjects in the pooled analysis, 93.8% had stage IV disease, 33.7% had brain metastases, and 27.1% had received chemotherapy. TRUST-I included Chinese subjects who were either new to TKIs or who had received crizotinib. TRUST-II included patients from North America, Europe, and Asia who were TKI-naive or who had been treated with crizotinib or entrectinib. The efficacy population included 157 patients (103 in TRUST-I; 54 in TRUST-II) who were naive to treatment with a ROS1 TKI and 113 patients (66 in TRUST-I; 47 in TRUST-II) who had received one prior ROS1 TKI. Patients may have received prior chemotherapy for advanced disease. For treatment-naive patients, the overall response rate (ORR) was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of responders having a duration of response (DOR) of at least a year, respectively. For TKI-pretreated patients, ORR was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83% of responders having a DOR of at least 6 months, respectively. Among 13 patients with a G2032R mutation, which triggers resistance to first generation ROS1 TKIs, eight (61.5%) had a response to taletrectinib. In a safety analysis with 352 patients, the most frequent treatment-emergent adverse events with taletrectinib were gastrointestinal problems (88%) and elevated aspartate aminotransferase (72%) and alanine aminotransferase (68%). Neurologic adverse events included dizziness (21%) and dysgeusia (15%). Overall, 33% of patients had grade 3 or higher treatment-related adverse events. Treatment-emergent adverse events led to discontinuation in 7% of patients. There were three treatment-related deaths due to abnormal hepatic function, liver failure, and pneumonia. Prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. The recommended taletrectinib dose is 600 mg orally once daily on an empty stomach until disease progression or unacceptable toxicity. Taletrectinib pricing was not available, but fourteen 160 mg capsules of rival repotrectinib — the initial 2-week supply with daily dosages doubling afterwards — is $7,666.97, according to
Yahoo
2 hours ago
- Yahoo
Study: Real-world results of GLP-1 drugs don't match trials
Real-world results for blockbuster weight-loss meds like Ozempic, Wegovy and Zepbound aren't as impressive as those promised by the drugs' clinical trials, a new study says. People taking such GLP-1 drugs lost just under 9% of their body weight on average after a year, researchers reported Tuesday in the journal Obesity. That's far less than the 15% to 21% body weight reduction promised by the clinical trials that led to the approval of Wegovy (semaglutide) and Zepbound (tirzepatide) for weight loss, researchers said. "Patients treated for obesity with semaglutide or trizepatide lost less weight on average in a regular clinical setting compared to what is observed in randomized clinical trial," lead investigator Hamlet Gasoyan said in a news release. He is a researcher at the Cleveland Clinic Center for Value-Based Care Research. People taking the drugs in real-world settings appear to be more likely to quit taking the meds, researchers said. They also might be prescribed lower dosages in clinical practice than were used in the drug trials. Glucagon-like peptide-1 (GLP-1) drugs mimic the GLP-1 hormone, which helps control insulin and blood sugar levels, decreases appetite and slows digestion of food. For this study, researchers tracked nearly 7,900 patients being treated by the Cleveland Clinic for severe obesity, of whom about 6,100 were prescribed semaglutide and the rest tirzepatide. Average body weight loss after a year was nearly 9% for the whole group, results show. But weight loss varied based on when a person stopped taking the drugs, researchers found. Average weight loss was under 4% for those who stopped treatment early, versus nearly 7% or those who stopped later on, the study says. Those who stayed on their medications lost an average 12% body weight. Results also show that more than 4 in 5 (81%) of patients were prescribed a low maintenance dose of their GLP-1 drug, and that made a difference as well. People who stayed on their meds and received high doses lost nearly 14% of their body weight with semaglutide and 18% with tirzepatide. "Our findings about the real-world use patterns of these medications and associated clinical outcomes could inform the decisions of health care providers and their patients on the role of treatment discontinuation and maintenance dosage in achieving clinically meaningful weight reductions," Gasoyan said. Overall, patients had higher odds of losing 10% or more of their body weight after a year if they remained on their meds, were prescribed a high dosage, were taking tirzepatide rather than semaglutide, and were female, results show. The cost of the drugs and problems were insurance were a common reason for patients stopping GLP-1 treatment, along with side effects and medication shortages, researchers said. Staying on the GLP-1 meds particularly helped the nearly 17% of patients who had prediabetes, a condition in which elevated blood sugar levels increase a person's risk of developing Type 2 diabetes. About 68% of those who stuck with their treatment wound up with normal blood sugar levels, compared with 41% who stopped taking the drugs later in the study and 33% who stopped earlier. "Type 2 diabetes is one of the most common complications of obesity, so diabetes prevention is very important," Gasoyan said. "This study highlights that treatment discontinuation, especially early, negatively affects both weight and glycemic control outcomes." A follow-up study is in the works to better track why patients stop taking their GLP-1 drugs, researchers said. More information Harvard Medical School has more on GLP-1 drugs. Copyright © 2025 HealthDay. All rights reserved.