Orforglipron · Regulatory label update

FDA supplemental approval: Foundayo (Labeling)

U.S. Food and Drug Administration · August 4, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is an FDA supplemental approval action for labeling changes to Foundayo (orforglipron), a tablet product available in four dose strengths (0.8, 2.5, 5.5, and 14.5 mg base). The record documents regulatory authorization only and does not report clinical trial results, efficacy, safety outcomes, or comparative benefit.

What was studied

Regulatory label update.

Key findings

Safety

This record is a regulatory approval action and does not contain clinical trial data, efficacy results, or safety outcomes.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of labeling changes for orforglipron (Foundayo); regulatory action without clinical trial data reported.

Caveats

This record is a regulatory approval action and does not contain clinical trial data, efficacy results, or safety outcomes.
The specific labeling changes are not detailed in this submission record.
No comparative data, absolute or relative effect sizes, or clinical endpoints are reported.
Reader must consult the full product label or prescribing information for clinical guidance.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory action; no study design applicable.

Directness

insufficient

Labeling record does not report clinical outcomes or comparative data.

Consistency

insufficient

No comparative or prior data presented in this submission.

Risk of bias

insufficient

Regulatory submission; not a clinical study.

Sample adequacy

insufficient

No human subject data reported in this labeling submission.

What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application NDA220934. This is a regulatory action record, not a clinical study. Brand name: FOUNDAYO. Active ingredient: ORFORGLIPRON. Sponsor: ELI LILLY AND CO. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-04. Products: FOUNDAYO, TABLET, ORAL, ORFORGLIPRON CALCIUM EQ 2.5MG BASE; FOUNDAYO, TABLET, ORAL, ORFORGLIPRON CALCIUM EQ 14.5MG BASE; FOUNDAYO, TABLET, ORAL, ORFORGLIPRON CALCIUM EQ 5.5MG BASE; FOUNDAYO, TABLET, ORAL, ORFORGLIPRON CALCIUM EQ 0.8MG BASE.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

OrforglipronELI Lilly AND