Sabril

For refractory complex partial seizures. NDA 20427, held by Lundbeck Pharms LLC. Vigabatrin.

As of Nov 14, 2026, NDA 20427 (Sabril), held by Lundbeck Pharms LLC, was first approved by FDA on Aug 21, 2009, with 22 approved supplements and 0 published complete response letters.

First approved: Aug 21, 2009
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SABRIL is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; SABRIL is not indicated as a first line agent Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Jan 24, 2020	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 26, 2013	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 21, 2009	Original applicationNew molecular entity · Standard review	Approved	REMS Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sabril500MG · tablet;oral	Vigabatrin	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 29REMS	Approved	Letter
Sep 12, 2024	Supplement 27REMS	Approved	Letter
Oct 12, 2022	Supplement 26REMS	Approved	Letter
Oct 20, 2021	Supplement 25Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 20, 2020	Supplement 23Labeling · Standard review	Approved	Letter
Oct 2, 2020	Supplement 24REMS	Approved	Letter
Jan 24, 2020	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 12, 2019	Supplement 22REMS	Approved	Letter
Jul 31, 2019	Supplement 20Labeling · Standard review	Approved	Label Letter
May 31, 2019	Supplement 19REMS	Approved	Letter
Aug 21, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 23, 2017	Supplement 17REMS	Approved	Letter
Apr 27, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 21, 2016	Supplement 14REMS	Approved	Label Letter
Sep 18, 2015	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 3, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
Oct 26, 2013	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 26, 2013	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 26, 2013	Supplement 12Labeling · Priority review	Approved	Label Letter
Dec 14, 2012	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 11, 2012	Supplement 5Labeling	Approved	Label Letter
Jan 18, 2011	Supplement 2Labeling	Approved	Label Letter
Aug 21, 2009	Original applicationNew molecular entity · Standard review	Approved	REMS Review Letter Label

Identifiers

Application: NDA 20427
Drugs@FDA: Overview at FDA
Company: Lundbeck Pharmaceuticals 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