Flags with the logos of the Danish drug manufacturer Novo Nordisk, manufacturer of diabetes and weight loss treatment Ozempic and Wegovy are photos while the company presents the annual report to Novo Nordisk in Bagsvaerd, Denmark, February 5, 2025.
Mads Claus Rasmussen | AFP | Getty images
Novo Nordisk Marked a huge legal victory that largely restricts pharmacies aggravating the marketing or sale of cheaper and unprecedented versions of the Wegovy drug loss drug drugs and diabetes ozempic diabetes.
A federal judge in Texas Thursday rejected an aggravating pharmacies offer on Thursday to continue to make copies of Ozempic and Wegovy while a legal challenge concerning the shortage of these drugs is taking place. Who came in response to a trial in February of an aggravating commercial group against the determination of the Food and Drug Administration than the active ingredient of these drugs, the semaglutide, is no longer short in the United States
Patients flocked to cheaper Copycates when Ozempic and Wegovy were shortened in the past two years due to the arrow demand, or if they did not have an insurance cover for expensive treatments.
During the FDA’s devoid shortages, pharmacists can legally make versions made up of brand medicines. Many Télésanté companies, such as Hims and his ownalso proposed these copies. But drug manufacturers and certain health experts have pushed the practice because the FDA does not approve of aggravated medicines, which are essentially tailor -made copies prescribed by a doctor to meet the needs of a specific patient.
“We are delighted that the Court rejected the attempts of the compounds of undermining the FDA data decision that the shortage” of Sémaglutide is resolved, said Steve Benz, vice-president of Novo Nordisk, legal and American lawyer in a statement.
“Patient safety remains an absolute priority for Novo Nordisk and the vast national judicial actions that we have taken to protect Americans from health risks posed by illegitimate drugs’` semaglutide ” works, “he said, referring to more than 100 prosecution of the company against the composition of pharmacies and other entities of 32 states.
On Thursday, the American district judge Mark Pittman specifically refused the offer of the association of outsourcing installations for a preliminary injunction which would have prevented the FDA from taking measures against its members for having made copies of Sémaglutide.
This decision confirms the previous determination of the FDA according to which the shortage of semaglutide in the United States is completed and means that the FDA can now continue immediately after the so-called 503A pharmacies which make versions composed of semaglutide according to individual prescriptions for a specific patient.
These pharmacies are largely regulated by states rather than the FDA.
These pharmacies make drugs composed according to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA.
The decision also means that the FDA can start to target the 503B pharmacies regulated by the federal government, which make drugs composed in bulk with or without prescription, after May 22. The agency’s actions may include products of products and letters of warning to pharmacies.
Thursday’s decision follows another victory for Novo Nordisk. Another federal judge in Texas earlier this week ruled in favor of the drug drugs 503A, Medioak Pharmacy, permanently prohibiting the company from marketing or selling aggravated semaglutide.
Novo Nordisk and Eli Lilly Aggressively reprimanded composition pharmacies in the past two years because they have the arrow popularity of their weight loss and diabetes medications.
Eli Lilly has followed a similar legal process with shooting, the active ingredient in its Zepbound weight loss medication and the treatment of Mounjaro diabetes. The FDA declared the American shortage of shooting compared to last year, which prompted the same aggravating sales group to continue the FDA on the drug.
In March, a federal judge rejected the group’s request to worsen a preliminary injunction on the application of the FDA against its members for having made copies of Mounjaro and Zepbound. The composition group called on.