Lamotrigine · Regulatory label update

FDA supplemental approval: Lamotrigine (Labeling)

U.S. Food and Drug Administration · April 10, 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 granted on 10 April 2026 for a labeling change to lamotrigine tablets (25 mg, 100 mg, 150 mg, 200 mg oral tablets) manufactured by Glenmark Pharmaceuticals. The record documents a regulatory action only and does not contain clinical trial results, efficacy data, safety findings, or the nature of the labeling modification.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy endpoints, or safety data.

Who this may help

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

Plain-language summary

FDA supplemental approval of a labeling change for lamotrigine generic tablets; describes a regulatory action, not clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-10

Application numberANDA090169

Submission typeSupplemental—Labeling

Caveats

This record does not contain clinical trial results, efficacy endpoints, or safety data.
The specific labeling changes approved are not described in this regulatory record.
No information on comparator products, clinical outcomes, or evidence supporting the labeling modification is provided.
This approval action alone does not establish the clinical utility or practice-changing status of the product.

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 report clinical outcomes or trial data.

Consistency

insufficient

No comparative or replication data reported in this record.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No study population or sample size reported.

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 ANDA090169. This is a regulatory action record, not a clinical study. Brand name: LAMOTRIGINE. Active ingredient: LAMOTRIGINE. Sponsor: GLENMARK PHARMS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-10. Products: LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 25MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 200MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 100MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 150MG.

Follow from this

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

LamotrigineGlenmark Pharms