Gabapentin · Regulatory label update

FDA supplemental approval: Gabapentin (Labeling)

U.S. Food and Drug Administration · April 2, 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 for a labeling change to gabapentin tablets (600 mg and 800 mg oral formulations) by Alkem Labs, approved on 2 April 2026. The record does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update. United States.

Key findings

Safety

No clinical trial results, adverse event data, or efficacy endpoints are available from this source.

Who this may help

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

Plain-language summary

FDA supplemental approval action for gabapentin labeling; documents regulatory decision but does not report clinical trial data or efficacy evidence.

Study design

As stated by the source record.

SettingUnited States

Caveats

This is a regulatory approval record, not a clinical study; no trial outcomes, efficacy data, or comparative benefit information is reported.
The specific labeling changes made are not described in this record.
No clinical trial results, adverse event data, or efficacy endpoints are available from this source.
The record does not indicate which indication(s) or population(s) the labeling change applies to.

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

Labeling supplement only; clinical outcomes not described.

Consistency

insufficient

Single regulatory action; no comparative or replicated data.

Risk of bias

insufficient

Regulatory record; methodological quality not assessable.

Sample adequacy

insufficient

Regulatory action; no trial population or sample size reported.

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

Source abstract

Drugs@FDA record for application ANDA206402. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-02. Products: GABAPENTIN, TABLET, ORAL, GABAPENTIN 800MG; GABAPENTIN, TABLET, ORAL, GABAPENTIN 600MG.

Follow from this

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

GabapentinAlkem Labs