Lamotrigine · Regulatory label update

FDA supplemental approval: Lamotrigine (Labeling)

U.S. Food and Drug Administration · April 13, 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 a labeling change to lamotrigine tablets (25, 100, 150, and 200 mg oral formulations) submitted by Alembic Pharmaceuticals on 13 April 2026. This record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Supplemental approval for labeling change to lamotrigine tablets (ANDA090607)

Safety

This record does not contain clinical trial results, efficacy data, safety findings, or the specific nature of the labeling change.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for a labeling change to lamotrigine tablets; it documents a regulatory decision, not clinical trial evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-13

SponsorALEMBIC PHARMS LTD

Submission typeSupplemental (labeling)

Approved strengths25 mg, 100 mg, 150 mg, 200 mg tablets, oral

Caveats

This record does not contain clinical trial results, efficacy data, safety findings, or the specific nature of the labeling change.
No comparative data, patient outcomes, or risk–benefit analysis is reported.
The record identifies only that a labeling supplement was approved; the actual labeling changes are not described in 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 clinical study design reported.

Directness

insufficient

Record documents labeling action only; no clinical outcomes reported.

Consistency

insufficient

Single regulatory action; no comparative or replicate data provided.

Risk of bias

insufficient

Regulatory submission; risk of bias framework does not apply.

Sample adequacy

insufficient

No clinical trial or patient cohort data reported in this record.

Source abstract

Drugs@FDA record for application ANDA090607. This is a regulatory action record, not a clinical study. Brand name: LAMOTRIGINE. Active ingredient: LAMOTRIGINE. Sponsor: ALEMBIC PHARMS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-13. 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.

Alembic PharmsLamotrigine