The U.S. Food and Drug Administration approved Mounjaro (tirzepatide) on May 13, 2022. The approval was recorded under NDA 215866, with Eli Lilly and Co. identified as the sponsor.
The FDA record classified the application as Type 1 - New Molecular Entity. The supplied record does not state the approved indication, patient population, dosing information, clinical-trial results, or safety findings.
Background
Tirzepatide is listed in the FDA record under the brand name Mounjaro. Related names supplied in the record include Mounjaro KwikPen, Zepbound, and Zepbound KwikPen. The event concerns the FDA's initial approval of Mounjaro under NDA 215866.
The available data identify the product and regulatory classification but do not provide a drug class, mechanism of action, disease indication, or information about prior approvals. Those details are therefore not included here.
What this means
The event documents an FDA approval for Mounjaro, the tirzepatide product sponsored by Eli Lilly and Co. The Type 1 classification indicates that the application was recorded as a new molecular entity in the supplied FDA data.
This record alone does not establish the approved use, the population eligible for treatment, the benefit-risk findings, or the conditions attached to the approval. Readers seeking those details should consult the FDA application record and associated labeling or approval documents.
Source
Source: U.S. Food and Drug Administration, Drugs@FDA application overview for Mounjaro (tirzepatide), NDA 215866, documenting the original FDA approval dated May 13, 2022. The source is hosted at accessdata.fda.gov.