The legal battle continues between the ability to produce blockbuster weight loss drugs such as SEMAGLUTIDE, which the latter party marketed by Novo Nordisk with Wegovy between the FDA and the complex pharmacy, and the Tirzepatide marketed by ELI Lilly and the marketing ability. After removing these drugs from the FDA tribal list, the Communityers Trade Group Outsourcing Facility Association (OFA) filed a lawsuit to continue to create advantageous drugs.
Now, NOVO has followed Lily to insert themselves into a subtle legal situation, as the US federal judge refuses to prohibit the OFA to continue to create a Zepbound copy. Reuters Reported.
Judge T. Fitman in the US District Court in northern Texas is Novo Nordic on Wednesday. Incident on FDA by OFA Several stores reported by removing Wegovy from the list of lack of the agency. This decision comes Two months After the court gave Lilly a similar permit for a separate lawsuit, OFA submitted the OFA on the date of submitting the OFA order after the FDA’s shortage of the FDA.
OFA’s most recent suitThe Trade Organization calls the FDA’s decision as “reckless and arbitrary decision.” It claims that it will deprive you of an important treatment patient for type 2 diabetes, obesity, cardiovascular disease and other serious medical conditions.
Pittman rejected NOVO’s request to be involved in this incident, but he had made an early ruling, but canceled the decision after Danish Pharmaceuticals submitted a new consent on Wednesday. Far away with Wegovy and Ozempic Best sales NOVO has a significant interest in the FDA’s ahead of $ 8 billion in 2024 and $ 16.9 billion for the latter, and the compiler effectively prohibits the compiler to make a knock -off copy.
When the institution declared a lack of drugs, Congress decided that doctors, pharmacists, or license outsourcing facilities could combine drugs suitable for the needs of patients. If Semaglutide is no longer in that state, the complex pharmacy is no longer legally approved to create its own drug version. According to the lawsuit, since the FDA was placed on a list of lack of Semaglutide in 2022, the demand for patients was met thanks to pharmacy and outsourcing facilities.
The latest litigation reflects the lawsuit closely Submitted by OFA in October 2024 When the FDA ends the lack of ELI Lilly’s GLP-1 + GIP combo, Tirzepatide. Agency check In December, Tiri discipleship was no longer short enough and gave a 90 -day compound to stop the production of the complex. Lily was eventually It was approved by intervention In that fight, it is before the same federal court.
OFA later ordered a preliminary prohibition. controversy The FDA has made a decision that can be applied to the entire complex industry. At this point, it is not clear if this is a banned order that was rejected on Wednesday. The decision of the rules of the agency provides strict requirements such as notification and participation in the public in complex periods under the Administrative Procedure Act.
Last year, the question of the FDA’s protocol to manage the list of drug shortages before the Chevron Deference was overturned. Agency at the pressure of the parties like OFA You can face the challenge This mechanism controls the drug supply chain. GLP-1 weight loss space is especially visible. Flourish In addition to the complex, the research peptide manufacturer originally meets the unsatisfactory demands of sending WEGOVY and Zepbound to the FDA’s lack of list.
Editor Note (March 6): This story has been pointed out to include news about the court’s ruling on the case related to Ellie Lily.
