Eplerenone · Regulatory label update

FDA supplemental approval: Eplerenone (Labeling)

U.S. Food and Drug Administration · May 20, 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 approval record for a supplemental application to update labeling for generic eplerenone (25 mg and 50 mg tablets). The document confirms FDA approval of labeling changes but does not report clinical trial results, efficacy, safety outcomes, or comparative data.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental application ANDA208283 for eplerenone labeling on 2026-05-20 Products approved: eplerenone 25 mg and 50 mg oral tablets (generic formulation by Breckenridge)

Safety

This is a regulatory approval record; it does not contain clinical trial results, efficacy data, or safety comparisons. No information provided on the underlying basis for the labeling change or any new safety or efficacy signals.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling changes to generic eplerenone; describes a regulatory action, not clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-05-20

Dosage strengths approved25 mg, 50 mg

Caveats

This is a regulatory approval record; it does not contain clinical trial results, efficacy data, or safety comparisons.
The specific labeling changes are not detailed in this record.
No information provided on the underlying basis for the labeling change or any new safety or efficacy signals.

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 reported.

Directness

insufficient

No clinical outcome or comparative data presented in this labeling approval.

Consistency

insufficient

Single regulatory action; no comparative or confirmatory data provided.

Risk of bias

insufficient

Not applicable to regulatory approval record.

Sample adequacy

insufficient

No trial population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA208283. This is a regulatory action record, not a clinical study. Brand name: EPLERENONE. Active ingredient: EPLERENONE. Sponsor: BRECKENRIDGE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-20. Products: EPLERENONE, TABLET, ORAL, EPLERENONE 25MG; EPLERENONE, TABLET, ORAL, EPLERENONE 50MG.

Follow from this

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

EplerenoneBreckenridge