Lamotrigine · Regulatory label update

FDA supplemental approval: Lamotrigine (Labeling)

U.S. Food and Drug Administration · May 12, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval action granting labeling changes to lamotrigine tablets (25 mg, 100 mg, 150 mg, and 200 mg formulations) by Rubicon Research. The record does not contain clinical trial results, efficacy data, or safety findings; it is an administrative record of the regulatory decision only.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental application ANDA078625 on 2026-05-12 for lamotrigine tablet labeling changes Four oral tablet strengths approved: 25 mg, 100 mg, 150 mg, 200 mg

Safety

Record does not contain clinical trial results, efficacy data, or comparative safety evidence. No information on indication, dosing, adverse events, or clinical outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for lamotrigine tablets; regulatory action without clinical trial data or efficacy claims.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-12

Application numberANDA078625

Submission typeLabeling supplement

Caveats

Record does not contain clinical trial results, efficacy data, or comparative safety evidence.
Specific labeling changes are not detailed in this administrative record.
No information on indication, dosing, adverse events, or clinical outcomes.
This is a supplemental application only; underlying approval history not provided.

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 applicable.

Directness

insufficient

Labeling change only; no clinical endpoints or outcomes reported.

Consistency

insufficient

Single regulatory submission; no comparative data provided.

Risk of bias

insufficient

Regulatory administrative record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial or patient population data in record.

Source abstract

Drugs@FDA record for application ANDA078625. This is a regulatory action record, not a clinical study. Brand name: LAMOTRIGINE. Active ingredient: LAMOTRIGINE. Sponsor: RUBICON RESEARCH. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-12. Products: LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 100MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 150MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 25MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 200MG.

Follow from this

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

Rubicon ResearchLamotrigine