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Leuprolide Acetate · Regulatory label update
U.S. Food and Drug Administration · May 6, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval for a labeling change to leuprolide acetate 14 mg/2.8 mL (1 mg/0.2 mL) solution for subcutaneous injection, issued 6 May 2026 by Eugia Pharma. The record documents a regulatory action only and does not contain clinical trial data, efficacy results, or safety information.
Regulatory label update.
This is an FDA supplemental approval for a labeling change to leuprolide acetate 14 mg/2.8 mL (1 mg/0.2 mL) solution for subcutaneous injection, issued 6 May 2026 by Eugia Pharma. The record documents a regulatory action only and does not contain clinical trial data, efficacy results, or safety information.
This record does not report clinical trial results, efficacy data, or safety findings; it is a regulatory approval notice for a labeling supplement only.
The source did not state who this applies to in practice.
FDA supplemental approval for leuprolide acetate labeling; regulatory action record, not a clinical trial, so efficacy and safety data are not reported here.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA212963. This is a regulatory action record, not a clinical study. Brand name: LEUPROLIDE ACETATE. Active ingredient: LEUPROLIDE ACETATE. Sponsor: EUGIA PHARMA. 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.