Semaglutide · Regulatory label update

FDA supplemental approval: Wegovy (Manufacturing (CMC))

U.S. Food and Drug Administration · June 18, 2026

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AI Summary

This is an FDA supplemental approval of manufacturing (CMC) changes for Wegovy (semaglutide) dated 18 June 2026, affecting three formulations of the subcutaneous solution. The record documents regulatory clearance of production modifications but contains no clinical trial data, efficacy results, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for manufacturing changes to Wegovy on 2026-06-18 Three semaglutide formulations approved: 0.25 mg/0.5 mL, 1 mg/0.5 mL, and 2.4 mg/0.75 mL

Safety

This is a manufacturing regulatory submission; no clinical trial results, efficacy data, or safety data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval of manufacturing changes for Wegovy; no clinical efficacy or safety data are reported in this regulatory action.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Submission typeSupplemental (CMC)

Caveats

This is a manufacturing regulatory submission; no clinical trial results, efficacy data, or safety data are reported.
The record does not specify the nature of the manufacturing changes or CMC modifications approved.
No patient population, study design, or outcome measures are included in this regulatory action record.
Approval of manufacturing changes does not constitute evidence of clinical benefit or superiority.

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 submission; not a clinical study.

Directness

insufficient

Manufacturing record does not address clinical outcomes or efficacy.

Consistency

insufficient

No comparative data or prior results provided in this record.

Risk of bias

insufficient

Not applicable to manufacturing/CMC submission.

Sample adequacy

insufficient

Not applicable to manufacturing/CMC submission.

Source abstract

Drugs@FDA record for application NDA215256. This is a regulatory action record, not a clinical study. Brand name: WEGOVY. Active ingredient: SEMAGLUTIDE. Sponsor: NOVO. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-06-18. Products: WEGOVY, SOLUTION, SUBCUTANEOUS, SEMAGLUTIDE 1MG/0.5ML (1MG/0.5ML); WEGOVY, SOLUTION, SUBCUTANEOUS, SEMAGLUTIDE 0.25MG/0.5ML (0.25MG/0.5ML); WEGOVY, SOLUTION, SUBCUTANEOUS, SEMAGLUTIDE 2.4MG/0.75ML (2.4MG/0.75ML); WEGOVY, SOLUTION, SUBCUTANEOUS, SEMAGLUTIDE 2.4MG/0.75ML (2.4MG/0.75ML).

Follow from this

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

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