Lamotrigine · Regulatory label update

FDA supplemental approval: Lamotrigine KIT (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

The FDA approved a supplemental application for labeling changes to lamotrigine kit (Torrent Pharmaceuticals), effective 10 April 2026. This is a regulatory action on product labeling and does not report clinical trial outcomes, comparative efficacy, or safety data.

What was studied

Regulatory label update.

Key findings

Supplemental labeling approval for lamotrigine kit (ANDA078947) granted 2026-04-10

Safety

This record does not contain clinical trial results, efficacy data, or safety comparisons. No information on pharmacology, dosing recommendations, or clinical indications is reported.

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 kit; a regulatory action without clinical trial data reported.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-10

Products approvedLamotrigine 25 mg, 100 mg, 150 mg, 200 mg tablets

Caveats

This record does not contain clinical trial results, efficacy data, or safety comparisons.
The nature of labeling changes is not specified in the source.
No information on pharmacology, dosing recommendations, or clinical indications is 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 study design applicable.

Directness

insufficient

Labeling action; clinical trial outcomes not reported.

Consistency

insufficient

Single regulatory submission; no comparative data provided.

Risk of bias

insufficient

Regulatory record does not assess study bias.

Sample adequacy

insufficient

No study population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA078947. This is a regulatory action record, not a clinical study. Brand name: LAMOTRIGINE KIT. Active ingredient: LAMOTRIGINE. Sponsor: TORRENT PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-10. Products: LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 200MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 100MG; LAMOTRIGINE, TABLET, ORAL, LAMOTRIGINE 150MG; LAMOTRIGINE, TABLET, 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.

Torrent PharmsLamotrigine