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STAT+: Novo asks FDA to bar compounders from making Ozempic copies

STAT

Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make.

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As Eli Lilly, compounders battle over weight loss drugs, patients are caught in the middle

STAT

Last week, the Food and Drug Administration declared an end to the shortage of Eli Lilly’s tirzepatide, sold under the brand name Mounjaro for diabetes and Zepbound for obesity.

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STAT+: Compounding group sues FDA for removing Lilly’s obesity drug from its shortages list

STAT

A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list. Continue to STAT+ to read the full story…

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STAT+: Pharmalittle: We’re reading about compounded Wegovy, pharmacies suing GoodRx, and more

STAT

… Novo Nordisk disclosed that it is aware of 10 deaths and 100 hospitalizations resulting from people taking compounded copies of its weight loss and diabetes drugs , Reuters writes. Given all the U.S. could inject themselves with a product that was not regulated, approved, or inspected.

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STAT+: Pharmalittle: We’re reading about Novo targeting compounded obesity drugs, an Amgen ‘at risk’ launch, and more

STAT

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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STAT+: Lilly sues compounders, wellness centers and spas over unapproved versions of Mounjaro

STAT

As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. for selling unapproved versions of its Mounjaro diabetes drug, which is frequently used for combating obesity.

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Novo joins Lilly in asking FDA for ban on GLP-1 compounding

pharmaphorum

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.