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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…

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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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STAT+: In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list

STAT

The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs. 

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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+: 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+: Eli Lilly weight loss drug shortage underscores deeper issues with FDA oversight

STAT

Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years. By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list. 

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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.