Lamotrigine · Regulatory label update

FDA supplemental approval: Lamotrigine (Labeling)

U.S. Food and Drug Administration · April 9, 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 application for labeling changes to lamotrigine tablets (25 mg, 100 mg, 150 mg, and 200 mg oral formulations) manufactured by Unichem Labs Ltd on 9 April 2026. This is a regulatory action record documenting approval of the submission; it does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, comparative efficacy data, or safety study outcomes. No information on trial populations, sample size, efficacy endpoints, or adverse event data is provided.

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; this is a regulatory action record, not a clinical trial, and does not report efficacy or safety trial data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-09

Application numberANDA090170

Submission typeSupplemental—Labeling

Caveats

This record does not contain clinical trial results, comparative efficacy data, or safety study outcomes.
The specific labeling changes approved are not detailed in this record.
No information on trial populations, sample size, efficacy endpoints, or adverse event data is provided.
Record does not specify the rationale or clinical justification for labeling changes.

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 present.

Directness

insufficient

Record does not specify clinical outcomes or direct patient benefit claims.

Consistency

insufficient

No comparison or consistency assessment reported in regulatory record.

Risk of bias

insufficient

Regulatory action; bias assessment framework does not apply.

Sample adequacy

insufficient

No clinical sample or trial population described in record.

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

Source abstract

Drugs@FDA record for application ANDA090170. This is a regulatory action record, not a clinical study. Brand name: LAMOTRIGINE. Active ingredient: LAMOTRIGINE. Sponsor: UNICHEM LABS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-09. Products: LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 150MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 25MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 200MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 100MG.

Follow from this

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

Unichem LabsLamotrigine