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Tuesday, October 8, 2024

Lilly obesity drug shortage ends fueling lawsuit against FDA

 An industry group representing companies that manufactured the copycat versions of Eli Lilly's (NYSE:LLY) highly popular weight loss therapy tirzepatide sued the U.S. FDA on Monday over the agency's decision to declare an end to the drug's shortage last week. 

The Outsourcing Facilities Association claimed in its lawsuit filed in federal court in Fort Worth, Texas, that the FDA removed the GLP-1 receptor agonist from its shortage list even though the drug remains in short supply.

The group represents makers of compounded versions of drugs that benefit from shortages of branded FDA-approved medications like tirzepatide and Novo's (NVO) rival weight loss therapy, semaglutide.

Hims & Hers Health (HIMS), which operates a compounding business targeting semaglutide, fell on Thursday after the FDA officially announced an end to its shortage.

The agency's decision to call an end to the tirzepatide shortage was arbitrary, capricious, and "contrary to law," the group alleged.

Due to increased demand, tirzepatide, marketed as Mounjaro for diabetes and Zepbound for weight loss, has been in shortage since 2022.

https://www.msn.com/en-us/money/companies/eli-lilly-obesity-drug-shortage-ends-fueling-lawsuit-against-fda/ar-AA1rTsqx

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