Gabapentin · Regulatory label update

FDA supplemental approval: Gabapentin (Labeling)

U.S. Food and Drug Administration · June 25, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental labeling change for gabapentin tablets (600 mg and 800 mg formulations) on 25 June 2026. This record confirms a regulatory action but does not disclose the content of the labeling revision or any supporting clinical or safety data.

What was studied

Regulatory label update. Patients receiving gabapentin 600 mg or 800 mg tablets.

Key findings

Supplemental approval granted for gabapentin labeling on 2026-06-25

Safety

No clinical trial results, efficacy data, or safety findings are provided

Who this may help

This is a labeling (administrative) action. Clinicians should expect revised prescribing information but should consult the updated label directly; this record does not specify what changed or why.

Plain-language summary

FDA supplemental approval action for gabapentin labeling changes; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-25

Clinical bottom line

This is a labeling (administrative) action. Clinicians should expect revised prescribing information but should consult the updated label directly; this record does not specify what changed or why.

Caveats

Record does not disclose the specific labeling changes made
No clinical trial results, efficacy data, or safety findings are provided
Reason for supplemental submission not stated
Content and scope of labeling revision unknown from this source

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 applicable.

Directness

insufficient

Labeling action; no clinical outcome data provided.

Consistency

insufficient

Single regulatory action; consistency not assessable.

Risk of bias

insufficient

Regulatory record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial data; sample size not applicable.

Source abstract

Drugs@FDA record for application ANDA077661. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: RUBICON RESEARCH. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-25. Products: GABAPENTIN, TABLET, ORAL, GABAPENTIN 600MG; GABAPENTIN, TABLET, ORAL, GABAPENTIN 800MG.

Follow from this

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

GabapentinRubicon Research