Novo Nordisk Legal Win Bats Many complex wegova, drugs

Novo Nordisk He won a huge legal victory, which largely limits the assembly of a pharmacy from marketing or sales of cheaper, unapproved versions of the drug hit in Wegova's slimming drug and OzMPIC diabetes treatment.

At the end of Thursday, the federal judge in Texas rejected the offer, combining pharmacies to constantly perform copies of Ozempi and Wegova, while a legal challenge is behaved about the lack of these drugs. This appeared in response to the February lawsuit from the commercial group against the establishment of the Food and Drug Administration that the active ingredient in these drugs, semaglutide, is no longer shorter in the United States

Patients came to cheaper followers when ozempic and Wegova in the last two years have equipped themselves with violent demand, or if they did not have insurance protection for expensive treatment.

While Deficiencies declared by the FDAPharmacists can legally create complex versions of branded drugs. Many Teradrowia companies, such as Him and herHe also offered these followers. But drug producers and some health experts have pushed into practice because the FDA does not approve the complex drugs that are basically made on request copies prescribed by a doctor to meet the needs of a specific patient.

“We are glad that the court has rejected attempts to undermine the FDA decision based on FDA, that the” semaglutide deficiency was dissolved, said Steve Benz, corporate vice president Novo Nordisk, legal and American general advisor, in a statement.

“The safety of patients remains the highest priority for Novo Nordisk, and extensive national legal actions that we have taken to protect Americans against health threats posed by illegal” semaglutide “drugs,” he said, referring to more than 100 processes against the submission of pharmacies and other entities in 32 states.

On Thursday, the US District Judge Mark Pittman specially refused to offer the Outsourcing Facilites Association for a preliminary order that would prevent FDA from taking action against members to perform a copy of semaglutide.

This decision maintains the FDA determining earlier that the semaglutide deficiency in the US is over and means that the FDA can now immediately pass through the so -called 503a pharmacies, which create complex versions of semaglutide in accordance with individual prescriptions for a specific patient.

These pharmacies are largely regulated by you, not the FDA.

These pharmacies produce complex drugs in accordance with individual prescriptions for a specific patient and are largely regulated by the states, not the FDA.

The decision also means that the FDA may start aiming at the 503B federal pharmacies, which produce complex drugs loose with or without prescriptions, after May 22. The agency's activities may include product attacks and warning lists for pharmacies.

The decision on Thursday comes from another win for Novo Nordisk. Another federal judge in Texas at the beginning of this week ruled in favor of the drug manufacturer against the pharmacy 503a, Aptece Medioak, permanently prohibits the activities of marketing or sales of the complex semaglutigu.

Novo Nordisk i Eli Lilly Over the past two years, pharmacies have ignited aggressively because they benefit from the growing popularity of weight loss and drugs for diabetes.

Eli Lilly passed through A similar legal process With dividers, the active ingredient in the treatment of slimming and treatment of Mounjaro diabetes. The FDA announced a deficiency of the American tirin last year, which prompted the same commercial group to sue FDA in relation to the drug.

In March, the federal judge rejected the application of a group submitted for a preliminary order to enforce FDA law against members in order to perform a copy of Mounjaro and Zepbound. The complex group appealed.