FDA approves first labeling changes for Mounjaro since its 2022 approval

The FDA approved two labeling supplements for Mounjaro (tirzepatide) on July 28, 2023, the first changes to the drug's Medication Guide, carton labels and package insert since the medicine was approved in May 2022 ^[1].

Both supplements sit under New Drug Application 215866, held by Eli Lilly and Co. ^[1]. Supplement S-002 covered container and carton labels, the Medication Guide and the package insert. Supplement S-006 covered the package insert alone. The FDA lists one combined label document for the two actions, plus a review document for S-002 ^[1]. The record lists which parts of the labeling changed but not the wording of those changes, so the specific text added, removed or reworded on July 28, 2023 has not been disclosed in the approval history ^[1].

Mounjaro's original approval came on May 13, 2022, as a Type 1 new molecular entity reviewed on priority status ^[1]. The same NDA covers 24 listed product entries at that time of the record: single-dose pens at 2.5, 5, 7.5, 10, 12.5 and 15 mg per 0.5 mL, an autoinjector version of those six strengths, and multi-dose KwikPen presentations ranging from 10 mg to 60 mg per 2.4 mL ^[1]. Mounjaro's active ingredient is tirzepatide, which is not the same molecule as semaglutide, the ingredient in Ozempic, Wegovy and Rybelsus.

The July 2023 action was the first of a long series. FDA records list later labeling supplements on November 1, 2024 (S-010, S-015 and S-022, touching the package insert and, for S-022, the Medication Guide), May 28, 2025 (S-031, package insert), September 25, 2025 (S-034, package insert and Medication Guide), and January 20, 2026 (S-009, carton and container labels, Medication Guide and package insert) ^[1]. Other supplements changed the drug's approved uses rather than its labeling: S-039 was cleared December 19, 2025 as a new patient population, and S-044 and S-045 were cleared August 27, 2026 as a new indication and a new dosing regimen ^[1]. One supplement, S-052, is listed as a package insert labeling action with no action date shown ^[1].

Why it matters for patients

The three items changed in July 2023 reach patients in different ways. The Medication Guide is the FDA-approved handout written for patients and dispensed with the drug. Carton and container labeling is what appears on the box. The package insert is the prescribing information written for clinicians, and it is the document that carries the approved uses, dosing, warnings and side effects ^[1].

Because the insert has been revised many times since 2022, a Mounjaro box, handout or prescribing document from one period may not read the same as a later one. Patients who compare versions, or who read a copy saved from an earlier year, may see different text. The FDA's listing identifies the type of each supplement — labeling, manufacturing, efficacy — but not what each edit said, so it is not yet known which specific warnings, instructions or descriptions changed on July 28, 2023, or in the labeling-only actions that followed ^[1].

The two supplements approved in 2026 were different in kind, classified as a new indication and a new dosing regimen ^[1]. Those are the entries that can expand who the drug is approved to treat or how it is given. Labeling-only supplements, by contrast, sit in the same approval category as the July 2023 pair.

What happens next

No action date is listed for one remaining package insert labeling supplement, S-052, and the FDA record does not state when a decision is expected ^[1]. For readers tracking changes to Mounjaro's instructions, the FDA approval history for NDA 215866 is the record that lists each approved label version by date ^[1].