Vigabatrin

For refractory complex partial seizures. ANDA 215519, held by Carnegie. Vigabatrin.

As of Nov 15, 2026, ANDA 215519 (Vigabatrin), held by Carnegie, was first approved by FDA on Apr 28, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2023
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Apr 28, 2023	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vigabatrin500MG · tablet;oral	Vigabatrin	Rx

All 3 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 2REMS	Approved	None posted
Sep 12, 2024	Supplement 1REMS	Approved	None posted
Apr 28, 2023	Original application	Approved	REMS

Identifiers

Application: ANDA 215519
Drugs@FDA: Overview at FDA
Company: Carnegie

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