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Adjustments may be required to reflect accuracy in the estimated costs of the diagnoses and procedures under consideration

In its submission to FDA, Eli Lilly and Company relied on these proposed criteria and claimed that tirzepatide, the active ingredient in Mounjaro (tirzepatide) injection and Zepbound (tirzepatide) injection, meets at least two of these proposed criteriafirst because of the complexity of its formulation, and second because of the complexity in its required physiochemical or analytical testing

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