On December 20, 2024, the U.S. Food and Drug Administration approved a supplemental application for Zepbound (tirzepatide) under New Drug Application 217806. The FDA event was classified as an efficacy action and identified Eli Lilly and Co. as the sponsor.
Background
The regulatory record concerns Zepbound, a brand name for tirzepatide. The supplied data also list Zepbound KwikPen, Mounjaro, and Mounjaro KwikPen among tirzepatide’s aliases. The event was described as an FDA-approved supplemental application for efficacy, designated NDA 217806 S-13.
The available event data do not specify a new disease indication, patient population, dosing change, contraindication, boxed warning, or other labeling change. They also do not provide clinical-trial enrollment, treatment arms, outcome measurements, or comparative efficacy values.
Regulatory action
The FDA recorded the action as a supplemental application rather than a newly submitted original application. Its classification was Efficacy, and the associated external identifier was NDA217806-SUPPL-13. The event date in the supplied record was 20 December 2024.
Because the data block identifies the application category but does not include the underlying review findings, the record alone does not establish which efficacy endpoint supported the action, the size of any treatment effect, or whether the supplement changed the approved use of tirzepatide.
What this means
The action confirms that FDA approved an efficacy-related supplement for Zepbound (tirzepatide) on the stated date. For clinicians, researchers, patient advocates, and editors tracking the product’s regulatory history, the key identifiers are the drug, sponsor, application number, supplement designation, and FDA event date.
The supplied information does not support conclusions about response rates, symptom changes, weight changes, statistical significance, confidence intervals, adverse events, or the precise labeling language associated with the supplement. Those details would require the FDA’s underlying application review or labeling documents, if available.
Source
Source: U.S. Food and Drug Administration, Drug Approval Details overview for the supplemental application concerning Zepbound (tirzepatide), dated December 20, 2024. The source is hosted at accessdata.fda.gov and is associated with NDA 217806: accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA217806.