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October 10, 2025   
Health Law Weekly

U.S. Court in Indiana Says FDA Must Reconsider Whether Eli Lilly Medicine Qualified as Biological Product

  • October 10, 2025

The U.S. District Court for the Southern District of Indiana set aside the Food and Drug Administration’s (FDA’s) refusal to designate Eli Lilly and Company’s product “retatrutide” as a biological product. The court remanded to the FDA to reconsider whether the obesity, osteoarthritis, and diabetes medicine was at least “analogous to a protein” for purposes of the biological product determination.

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