Lamotrigine · Regulatory label update

FDA supplemental approval: Lamotrigine (Labeling)

U.S. Food and Drug Administration · July 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 lamotrigine orally disintegrating tablets (25 mg, 50 mg, 100 mg, 200 mg) on 13 July 2026 under ANDA 219677, submitted by Taro. This is a regulatory action concerning labeling and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental labeling for lamotrigine orally disintegrating tablets in four strengths: 25 mg, 50 mg, 100 mg, 200 mg

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval action for lamotrigine orally disintegrating tablet labeling; does not report clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-13

ANDA number219677

Caveats

This record does not contain clinical trial results, efficacy data, safety data, or comparative evidence.
The specific labeling changes approved are not detailed in this regulatory record.
No information on indications, contraindications, or clinical guidance is provided.
No sample size, endpoints, or patient demographics are reported.

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

Labeling approval; no clinical outcomes or comparators reported.

Consistency

insufficient

Single regulatory action; consistency with prior evidence not stated.

Risk of bias

insufficient

Regulatory submission; bias assessment not applicable or reported.

Sample adequacy

insufficient

No clinical sample or trial population described in this record.

Source abstract

Drugs@FDA record for application ANDA219677. This is a regulatory action record, not a clinical study. Brand name: LAMOTRIGINE. Active ingredient: LAMOTRIGINE. Sponsor: TARO. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-13. Products: LAMOTRIGINE, TABLET, ORALLY DISINTEGRATING, ORAL, LAMOTRIGINE 200MG; LAMOTRIGINE, TABLET, ORALLY DISINTEGRATING, ORAL, LAMOTRIGINE 50MG; LAMOTRIGINE, TABLET, ORALLY DISINTEGRATING, ORAL, LAMOTRIGINE 100MG; LAMOTRIGINE, TABLET, ORALLY DISINTEGRATING, ORAL, LAMOTRIGINE 25MG.

Follow from this

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

TaroLamotrigine