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Flags with the Danish Danish Novo Nordisk logo, Diabetes Blockbuster and Wegovy Wegovy Diabetes Manufacturers, while the company presents an annual report in Novo Nordisk in Bagsvaerd, Denmark, February 5, 2025.
Mads Claus Rasmussen | AFP | Gets the image
Novo nordisk He has gained a huge legal victory, which greatly restricts complex pharmacies from marketing or selling cheaper, unauthorized versions of drug addiction and diabetes drug addiction.
Federal Judge in Texas at the end of Thursday rejected the application, making pharmacies to continue to make copies of Ozempic and Wegovy, while the legal problem is unfolding about the lack of these medicines. This came in response to a February lawsuit against a complex trading group against the determination of the power management and medicine that the active substance in these drugs, semaglutide, no longer shorter in the US
Patients flocked to cheaper copies when Ozempic and Wegovy over the past two years have been insufficient because of rapid demand, or if they did not have an insurance coverage for expensive therapies.
During Specified FDA deficitPharmacists can legally make complex versions of the drugs. Many healthcare companies such as Its and herThey also offered these copies. But drug manufacturers and some health experts have pushed away from this practice, since the FDA does not approve of complex drugs that are essentially custom -made to meet the patient’s specific needs.
“We are glad that the court rejected the connectors’ attempts to blow up the FDA data on the lack of” Semaglutide, according to Steve Bezz’s statement, corporate vice president Novo Nordisk, the US Law and General Lawyer.
“Patient’s security remains a top priority for Novo Nordisk and the broad nationwide legal action we have started to protect Americans from health risks, which are unlucky” Semaglutid “,” he said, citing more than 100 trials of the company against complex pharmacies and other enterprises.
On Thursday, US District Judge Mark Pitman specifically denied the application of the outsourcing association for a preliminary ban that would prevented the FDA to take action against its members to create copies of Semaglutid.
This decision supports the pre -definition of the FDA that the Semaglutide deficit in the US has ended and means that the FDA can immediately go after the so -called 503a pharmacists, which create complex versions of semaglutide according to individual recipes for a particular patient.
These pharmacies are largely regulated by the states, not the FDA.
These pharmacies make complex drugs according to individual recipes for a particular patient and are largely regulated by states, not FDA.
The solution also means that the FDA can start targeting the federal regulation of 503b pharmacy, which produce complex medicines mainly with or without recipes, after May 22. The agency’s actions can include product steps and warning to the pharmacy.
The decision on Thursday follows from another victory for Novo Nordisk. Earlier this week, another Federal Judge in Texas ruled in favor of a drug manufacturer against a pharmacy 503A, a Medioak pharmacy, constantly banning business from marketing or selling sophisticated semaglutid.
Novo nordisk and Eli Lily Over the past two years, they have been aggressively enchanting into complex pharmacies as they have been popular with the popularity of their weight loss and diabetes.
Eli Lily survived A similar legal process With the Tirzepatide, the active substance in his drugs, and the treatment of Mounjaro diabetes. The FDA has announced a Tirzepatid deficit in the US over the past year, which forced the same complex trading group to sue the FDA for drugs.
In March, the federal judge denied a difficult group on a preliminary ban on FDA’s execution against its members for creating copies of Mounjaro and Zepbound. The complex group was appealed.
