Ozepic shortage has ended

American food and administration for medicines has determined that Semlutide is no longer shortfallA move that will have consequences for patients who take more expensive, complex versions of the drug.

Semaglutide, the active ingredient in Novo Nordisk’s blockbuster diabetes and weight loss medicines Ozepic and Wegovyhas been on Fda’s A list of shortage of March 2022. Delivery cannot be upset with A fervent search for the medicinethat have reached such dizzying levels of popularity that it has turned Novo Nordisk into one of the most valuable companies in the world, with market capitalization Lighter than the rest of the economy of its native nation in Denmark.

During the intervention years, lucrative industry of telephone companies, medical spa and pharmacies Developing and selling “sophisticated” copies Medicines have arisen. These out-of-brand copies are sold with a steep discount-somewhat under $ 100 per vial, they take the names with a brand with names that can be over $ 1,000 a month without insurance.

At the end of October, the FDA changed the condition of all doses of Ozmpic and Wegovy to “available”, signaling that the end of the official shortage is probably visible. To this day, almost four months later, for regulators to conclude that the medicine is accessible enough to remove it from the list of shortages.

FDA give “503A” connectors, typically licensed by the state, pharmacies or medical compounds that perform smaller operations until April 22 to stop producing the medicine. It gives the “503B” composition, which are more outsourced outsourcing facilities, which follow the more stringent directions for production until May 22.

In ordinary circumstances, it is not particularly debatable when drugs come out of a shortage list. But there is reason to believe that players in this industry will be repelled to this message.

Mixing the drug is a well -established practice; Pharmacists are allowed to make copies of drugs when there is a lack of medication or when patients need versions made at or without allergens. But the Boom GLP-1 has created the opportunity for connectors that have transformed the pockets of the industry, with pharmacies producing duplicates outside the brand for probable millions of patients.

Robert MacArthur, director of Pharmacy at Rockefeller University Hospital, says that after a medicine comes out of the FDA shortage list, outsourcing pharmacies that make large batches of complex medicines for healthcare, they no longer have to complicate this medicine. But for smaller, traditional pharmacies that make home -made medicines, this is a legal gray area.

“They can refine it if the doctor writes the recipe for an individual patient and thinks there is some convincing reason why this patient needs this special complex product,” says Phaertur. This reason may be to adjust the dose or adapt the drugs to a particular patient.

In December, the FDA said Tirzepatide, the other popular drug GLP-1, is no longer in shortages. The small connectors of 503A had 60 days to stop production, while the larger outsourcing of 503B was 90 days to end sales. Eli Lily, who sells tirzepatide under the trade names Mounjaro and Zepbound, sent a noise from Termination and Destining Letters to hundreds of companies that sell complex versions. The complex industry stepped back, as a trade group brought a lawsuit against the FDA, arguing that the medicine was actually still difficult for patients. Currently, the FDA has set deadlines for connectors to stop producing thyrcepatide products, but at the moment it does not apply the deadlines as the case continues.