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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+: FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period

STAT

The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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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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STAT+: What to know about concerns raised about compounded versions of Novo Nordisk’s Wegovy

STAT

In late May, the Food and Drug Administration said it received a “few” adverse event reports concerning compounded versions of the injectable medicines, which both contain the same active ingredient, known as semaglutide. The notice raised an important question: To what extent should the public be concerned?

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STAT+: Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA

STAT

Semaglutide, the scientific name for Novo’s GLP-1 diabetes drug Ozempic and obesity drug Wegovy, has been on the shortage list for over two years, with different doses being listed in shortage at various times.   Continue to STAT+ to read the full story…