Leuprolide Acetate · Regulatory label update

FDA supplemental approval: Leuprolide Acetate (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 action granting labeling changes to leuprolide acetate 14 mg/2.8 mL subcutaneous solution submitted by Somerset Therapeutics LLC on 6 May 2026. The record documents a regulatory action only and contains no clinical trial data, efficacy results, or safety findings.

What was studied

Regulatory label update. United States (FDA).

Key findings

Supplemental approval granted for leuprolide acetate labeling changes (ANDA213829)

Safety

No safety or efficacy outcomes are reported.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for labeling changes to leuprolide acetate; it does not report clinical trial outcomes or efficacy data.

Study design

As stated by the source record.

SettingUnited States (FDA)

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or comparative benefit information.
The specific nature and content of the labeling changes are not detailed in this record.
No safety or efficacy outcomes are reported.
Approval date is listed as future (2026-05-06); source currency cannot be verified.

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 study design present.

Directness

insufficient

Labeling change only; no clinical outcome data reported.

Consistency

insufficient

Single regulatory submission; consistency cannot be assessed.

Risk of bias

insufficient

Regulatory approval record; risk of bias assessment not applicable.

Sample adequacy

insufficient

No study population or sample size; regulatory record only.

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

Source abstract

Drugs@FDA record for application ANDA213829. This is a regulatory action record, not a clinical study. Brand name: LEUPROLIDE ACETATE. Active ingredient: LEUPROLIDE ACETATE. Sponsor: SOMERSET THERAPS LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-06. Products: LEUPROLIDE ACETATE, SOLUTION, SUBCUTANEOUS, LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML).

Follow from this

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

Leuprolide AcetateSomerset Theraps