US food and drug management identified that thing Semglutide no more defectA move will make sense for patients using cheaper, combined versions of the drug.
Semaglutide, active ingredient in Novo Nordisk's Blockbuster diabetes and weight loss pills Ozempic and wegovyabove FDA's The list of shortage since March 2022. The supply cannot keep up with The enthusiastic need for the drugreaching so dizzy level that it has turned Novo Nordisk into one of the most valuable companies in the world, with One market capitalization larger than the rest of the economy of its Danish nation.
Over the years, A profitable industry of Telehealth, medical spas and pharmacies Create and sell “combined” copies of the drugs that have arisen. Copies besides this brand are sold at a discount price sometimes less than 100 dollars a bottle compared to brand name drugs, maybe more than $ 1,000 a month without insurance.
At the end of October, the FDA changed the status of all the doses of Ozempic and Wegovy into existing, signaling that the end of the official shortage could be in a vision. It takes to this day, nearly four months later, so that the regulatory agencies conclude that the drug is widely available to remove it from the shortage list.
FDA is giving away The compounds of 503A, pharmacies are licensed by the state or the doctor's compounds run smaller activities, until April 22 to stop producing drugs. It is providing compounds of 503B 503B, which are larger processing facilities following more stricter production instructions, until May 22.
In normal cases, it is not particularly controversial when drugs are deficient in a shortlock. But there is a reason to believe that players in this industry will repel this notice.
Drug compounds are a well -established practice; The pharmacist is allowed to create copies of the drug when the drug is lacking or when the patient needs the versions performed in a specific dosage or no allergen. But the GLP-1 explosion has created an opportunity for the transformed compounds of the industry, with mixed pharmacies producing copies outside the brand for millions of patients.
Robert Macarthur, Director of Pharmaceutical at Rockefeller University Hospital, said that once a drug comes out of the FDA shortage list, software pharmacies create large mixed drugs for Cham facilities. Health squirrel is no longer created to create that medicine anymore. But for traditional mixed pharmacies, making medicine at home, it is a legal gray area.
They can combine it if the doctor wrote a prescription for an individual patient and felt some convincing reasons so that patients needed that special gross product, according to Mr. MacArthur. The reason may be adjusted or adjusted the drug for a specific patient.
In December, the FDA stated that Tirzepatide, a popular GLP-1 drug, is no longer missing. The 503A small compounds have 60 days to stop production, while the 503B processing facilities larger than 90 days to finish sales. Eli Lilly, a Tirzepatide seller under the brand name Mounjaro and Zepbound, sent a series The letters stop working For hundreds of companies that sell combined versions. The combined industry was pushed back, with a commercial group filing a lawsuit against the FDA, saying that this drug was still really difficult to access the patient. Until now, the FDA has set the deadline for compounds to stop producing Tirzepatide products, but it does not execute the deadline at this time when the case is taking place.