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A group representing pharmacies that produce external versions for the brand GLP-1 weight loss drugs only submitted another lawsuit against American food and medicine equipment (FDA). This time it is almost due to the decision on the Health Regulator for Removing Semaglutid – the active ingredient in Novo Nordisk (NGO+ 0.11%) Popular Okempic and Wegovy treatments – from his list of drug deficiency.
Semaglutide is on the list of the shortage of the Agency from 2022. Years. During this time, pharmacies, teleszer companies and other health care providers were able to give and sell what they are known as complex versions of drugs.
In his lawsuitOutsourcing Association (OFFA) claims that the Agency is “dismissing evidence that the shortage continues” and that his decision “will deprive patients of vital treatment”.
Semaglutide belongs to the class of medications known as GLP-1S, which have become very requested for their weight loss effects. Saail Sales for these treatments have transformed new Nordisk and its Rival Eli Lilly (Lly+ 2.45%)manufacturer of competing drugs MOUNJARO AND ZEP OF, IN Most valuable pharmacy companies in the world. However, the Hirotine demand and the price of a high list of medications made it difficult for some patients to fulfill their recipes.
Due to branded drug shortcomings, companies have managed to sell versions out of March. Usually food, drugs and cosmetic act prohibits complex medications that are just copies of commercially available medications. However, medications that have been in absence not considering the US food and medicine administration (FDA) to be commercially available. The joint means that the pharmacy or doctor adjusts the approved drug to suit the needs of individual patients.
The FDA also said that in Friday, it will start to cite companies and health services providers who continue to offer “essential copies” of complex semazlutides in the next 60 to 90 days.
This is another lawsuit that the AFA has filed against the FDA through complex weight loss drugs. Last October, group sued the agency over his decision to remove Tirzepatis – The active ingredient in Zepbount – from his creation for the shortage, making arguments similar to those in his latest lawsuits.
FDA said, in the submission of the court that the pharmacists could temporarily Continue making complex tyrzepatis How to re-examine his decision. Then, UA letter Since December, the agency stated that his overview revealed that Eli Lilly had enough supply to meet and transition and current and future drug demand. This case still lasts.
However, not all layers do not want to cause FDA on this.
“Complex pharmacists long knew that this disadvantage had a shelf life,” said Scott Brunner, the Director General of the Fairling of Pharmacy, UA statement.
Brunner also thanked the FDA for providing “off-ramp” to stop production – something that the agency did not initially offered with its decision of Tirzepatis.
FDA told Friday Friday that pharmacies and doctors with a state license, known as 503A, must stop making and distribute products for semalutids by 22. April. Outsourcing objects, known as 503b, have up to 223b.
2025-02-25 22:43:00
