Lamictal Xr

For partial-onset seizures. NDA 22115, held by Glaxosmithkline LLC. Lamotrigine.

As of Nov 13, 2026, NDA 22115 (Lamictal Xr), held by Glaxosmithkline LLC, was first approved by FDA on May 29, 2009, with 26 approved supplements and 0 published complete response letters.

First approved: May 29, 2009
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LAMICTAL XR is indicated for:

adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Apr 25, 2011	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label Pediatric Medical Review
May 29, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

6 strengths and forms


Lamictal Xr25MG · tablet, extended release;oral	Lamotrigine	RxReference drug
Lamictal Xr50MG · tablet, extended release;oral	Lamotrigine	RxReference drug
Lamictal Xr100MG · tablet, extended release;oral	Lamotrigine	RxReference drug
Lamictal Xr200MG · tablet, extended release;oral	Lamotrigine	RxReference drug
Lamictal Xr300MG · tablet, extended release;oral	Lamotrigine	RxReference drug
Lamictal Xr250MG · tablet, extended release;oral	Lamotrigine	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Oct 10, 2025	Supplement 34Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 10, 2025	Supplement 33Labeling · Standard review	Approved	Letter Label
Apr 25, 2025	Supplement 32Labeling · Standard review	Approved	Letter Label
Apr 25, 2025	Supplement 31Labeling · Standard review	Approved	Letter Label
Mar 31, 2021	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 9, 2020	Supplement 24Labeling · Standard review	Approved	Letter Label
Aug 31, 2020	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 25, 2019	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 14, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 23, 2018	Supplement 22Labeling · Standard review	Approved	Label Letter
Jun 27, 2018	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 24, 2015	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 24, 2015	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 30, 2014	Supplement 14Labeling	Approved	Label Letter
Dec 30, 2014	Supplement 4Labeling	Approved	Label Letter
Jun 10, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 20, 2013	Supplement 3Labeling	Approved	Letter Label
Aug 1, 2012	Supplement 17Labeling	Approved	Label Letter
Nov 29, 2011	Supplement 16Labeling	Approved	Label Letter
Aug 4, 2011	Supplement 13Labeling	Approved	Letter Label
Jun 21, 2011	Supplement 15Manufacturing	Approved	Label Letter
Apr 25, 2011	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label Pediatric Medical Review
Oct 24, 2010	Supplement 10Labeling	Approved	Label
Oct 24, 2010	Supplement 9REMS	Approved	Label
Apr 14, 2010	Supplement 5REMS	Approved	Label Letter
Apr 14, 2010	Supplement 1Manufacturing · Standard review	Approved	Letter Label
May 29, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22115
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters