Vigabatrin

For refractory complex partial seizures. ANDA 215109, held by Dexcel. Vigabatrin.

As of Nov 15, 2026, ANDA 215109 (Vigabatrin), held by Dexcel, was first approved by FDA on Sep 23, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 23, 2021
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vigabatrin tablets are 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; Vigabatrin tablets are 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 4 submissions below

Date	Submission	Status	Documents
Sep 23, 2021	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vigabatrin500MG · tablet;oral	Vigabatrin	Rx

All 4 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 4REMS	Approved	None posted
Sep 12, 2024	Supplement 3REMS	Approved	None posted
Oct 12, 2022	Supplement 2REMS	Approved	None posted
Sep 23, 2021	Original application	Approved	REMS

Identifiers

Application: ANDA 215109
Drugs@FDA: Overview at FDA
Company: Dexcel

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