Goserelin · Regulatory label update

FDA supplemental approval: Zoladex (Labeling)

U.S. Food and Drug Administration · May 6, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a regulatory notification of FDA supplemental approval for a labeling change to Zoladex (goserelin 3.6 mg implant) on 6 May 2026. The record documents the action taken by the regulator but does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory action record, not a clinical trial; no efficacy, safety, or comparative effectiveness data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to Zoladex (goserelin); does not contain clinical trial data and conveys only the regulatory action taken.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-06

Submission classLabeling

Active ingredient and strengthGoserelin 3.6 mg implant

Caveats

This is a regulatory action record, not a clinical trial; no efficacy, safety, or comparative effectiveness data are reported.
The specific nature of the labeling change is not described in this submission record.
No clinical outcomes, sample size, or study methodology are provided.
This approval does not imply new clinical evidence or changed 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 record; no clinical study design present.

Directness

insufficient

Labeling supplement; clinical outcome data not reported.

Consistency

insufficient

Single regulatory submission; no comparative or replicative data.

Risk of bias

insufficient

Regulatory record does not assess or report trial methodology.

Sample adequacy

insufficient

No sample size or trial population described in submission.

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

Source abstract

Drugs@FDA record for application NDA020515. This is a regulatory action record, not a clinical study. Brand name: ZOLADEX. Active ingredient: GOSERELIN. Sponsor: TERSERA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-06. Products: ZOLADEX, IMPLANT, IMPLANTATION, GOSERELIN 3.6MG.

Follow from this

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

TerseraGoserelin