Leuprolide Acetate · Regulatory label update

FDA supplemental approval: Vabrinty (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 U.S. FDA supplemental approval record for a labeling change to leuprolide acetate (ELIGARD KIT 30 mg subcutaneous powder, sponsor Tolmar) approved on 6 May 2026. The record does not contain clinical trial data, efficacy results, or details of the specific labeling modification.

What was studied

Regulatory label update.

Key findings

Safety

No safety or efficacy endpoints 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 leuprolide acetate; regulatory action does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-06

Product strength30 mg

Caveats

This record does not contain clinical trial results, efficacy data, or comparative outcomes.
The specific content of the labeling change is not described in this regulatory notification.
No safety or efficacy endpoints are reported.
No sample size, study design, or patient population is documented.

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 record; no study design reported.

Directness

insufficient

Labeling action; clinical endpoints not described.

Consistency

insufficient

No comparative data or prior evidence cited.

Risk of bias

insufficient

Regulatory approval record; study methodology not available.

Sample adequacy

insufficient

No population or sample size reported in this record.

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 NDA021488. This is a regulatory action record, not a clinical study. Brand name: VABRINTY. Active ingredient: LEUPROLIDE ACETATE. Sponsor: TOLMAR. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-06. Products: ELIGARD KIT, POWDER, SUBCUTANEOUS, LEUPROLIDE ACETATE 30MG.

Follow from this

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

Leuprolide AcetateTolmar