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US FDA Employs Familiar Strategy In Ending Novo’s Wegovy, Ozempic Shortage

 
• By Sue Sutter

A declaratory order removing semaglutide from the FDA shortages list duplicates much of the language in a December decision still in litigation that declared Eli Lilly’s tirzepatide products Mounjaro and Zepbound were no longer in shortage.

Empty shelves
The FDA said the shortage of Novo Nordisk's Wegovy and Ozempic is over. (Shutterstock)
Key Takeaways
  • The FDA removed Novo Nordisk’s weight loss drug Wegovy and type 2 diabetes treatment Ozempic from the drug shortages list, where they have been since March 2022 and August 2022, respectively.
  • The agency’s declaratory order on semaglutide is similar to its determination that tirzepatide products are no longer in shortage, a finding that still is being litigated by compounders and outsourcing facilities.
  • Numerous state attorneys general have asked FDA Acting Commissioner Sara Brenner to block imports of counterfeit GLP-1 products and crack down on unlawful compounding.

The US Food and Drug Administration’s determination that the shortage of Novo Nordisk’s semaglutide products has resolved is based on an approach still being litigated...

In a 21 February declaratory order, the agency removed Novo’s weight loss drug Wegovy and type 2 diabetes treatment Ozempic from the drug shortages list,...

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