FDA approves three labeling supplements for Mounjaro
Three Mounjaro labeling supplements approved the same day revised both the package insert and the patient-facing Medication Guide, but the FDA record does not say what changed.
On November 1, 2024, the Food and Drug Administration approved three labeling supplements for Mounjaro, the tirzepatide injection made by Eli Lilly, together revising the product's package insert and its Medication Guide, according to the agency's Drugs@FDA record for the application [1].
The three submissions are identified as S-010, S-015 and S-022, all with an action date of November 1, 2024 [1]. FDA classifies S-010 and S-015 as labeling-package insert supplements, and S-022 as covering both the package insert and the Medication Guide [1]. Rather than separate documents for each submission, the agency published one combined label and one combined approval letter covering all three [1].
Mounjaro is a subcutaneous solution of tirzepatide. The FDA listing for the application shows single-dose strengths of 2.5, 5, 7.5, 10, 12.5 and 15 milligrams per 0.5 milliliter [1]. The application, NDA 215866, was originally approved on May 13, 2022, and was reviewed as a Type 1 new molecular entity under priority review [1].
The FDA record lists the submission numbers, the action date and the categories of labeling affected, but not the wording that was added, removed or revised, and it contains no summary of the changes [1]. It does not state whether the revision involved safety information, instructions in the Medication Guide, or administrative text. The three supplements are not classified as new indications, new dosing regimens or new patient populations; the record shows those categories attached to other supplements at other dates [1].
The Drugs@FDA entry also shows that this application has been updated repeatedly since its 2022 approval, with supplements covering the package insert, container and carton labels, and the Medication Guide [1].
Why it matters for patients
FDA treats the package insert and the Medication Guide as separate parts of a drug's labeling, and the November 1 supplements touched both [1]. A revision means the printed materials a patient may have received earlier are not automatically the same as the version now on file [1].
What the supplements changed has not been disclosed in the application record, so it is not possible from that record to say whether the revision affects how Mounjaro is described, how it is used, what side effects are listed, or only how the information is worded [1]. The combined label published with the supplements is the version now on file for the application [1].
A labeling update is not the same as a new approval of the drug itself. Mounjaro's marketing status remains prescription, and the application retains reference-listed-drug status for the products listed under it [1].
What happens next
The FDA record does not list any further steps for S-010, S-015 or S-022 beyond the November 1, 2024 approval [1]. No summary of the revised wording appears in the application's entry, and the agency has not said whether one will be published [1].
Sources
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