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 an FDA supplemental approval action for a labeling update to Vabrinty (leuprolide acetate 45 mg subcutaneous injection) submitted by Tolmar. The record documents a regulatory decision but does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling update to leuprolide acetate; regulatory action does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-05-06

Active ingredient and doseLeuprolide acetate 45 mg

FormulationPowder for subcutaneous injection (ELIGARD KIT)

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific nature and content of the labeling changes are not disclosed in this regulatory record.
No comparative evidence, study design, or sample size information is provided.
This is a supplemental approval; background clinical data supporting the original application are not included here.

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 clinical study design present.

Directness

insufficient

Labeling action only; clinical outcomes not reported.

Consistency

insufficient

Single regulatory action; no comparative evidence presented.

Risk of bias

insufficient

Regulatory record does not report trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or population data reported in labeling supplement.

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 NDA021731. 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 45MG.

Follow from this

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

Leuprolide AcetateTolmar