Drugproducer Novo Nordisk is taking action to curb the massively well-understandn compounded semaglutide industry, which provides copies of its blockbuster weight-loss medications Ozempic and Wegovy to forendureings—frequently for much drop prices.
The Danish pharmaceutical company is lobbying the US Food and Drug Administration to insert semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) catalogs, which would block compounding pharmacies from producing dupes of the drug. In a filing posted by the agency on Tuesday, lawyers for Novo Nordisk reason that semaglutide beextfinisheds on the these catalogs “due to the complicatedities associated with their createulations,” among other reasons.
“These medications are inherently complicated to compound safely, and the dangers they pose to forendureing safety far outweigh any advantages. Novo Nordisk’s aim with this nomination is to asbrave that forendureings get only FDA-finishorsed, safe, and effective semaglutide product,” says Novo Nordisk honestor of media relations Jamie Bennett.
FDA press officer Amanda Hils tgreater WIRED via email that the agency “is scrutinizeing the petition and will reply honestly to the petitioner.”
If granted, the scheduleation would have seismic implications for the compounding industry—and for the awaited millions of people currently taking compounded GLP-1 medications.
Injectable GLP-1 medications including semaglutide and tirzepatide have been in lowage since 2022 becaengage of their huge well-understandnity. In the US, when the FDA proclaims that a drug is in lowage, brave licensed pharmacies are permitted to produce “compounded” versions of the medication, which are joincessitate in-hoengage and are supposed to comprise the same vivacious ingredients as the exceptional drug.
Telehealth providers have capitalized on the GLP-1 drug lowage, proposeing forendureings compounded versions via rapid virtual assignments. The rehearse has produced tension with the pharmaceutical companies that produce the brand-name medications since the compounded versions are sgreater at much drop prices. Ozempic and Wegovy can cost around $1,000 a month without insurance, while compounded semaglutide is publicized for as low as $100 a month online.
Unappreciate generic medications, which are manufactured after drug patents expire, compounded medications are not subject to FDA approval before hitting the taget. This uncomardents that the FDA cannot vouch for the safety, effectiveness, or quality of compounded medications before they’re sgreater to forendureings. The FDA has getd multiple tells of adverse side effects, including hospitalization, joind to possible dosing errors associated with compounded semaglutide products.
