Vigabatrin

For refractory complex partial seizures. ANDA 214749, held by Upsher Smith Labs. Vigabatrin.

As of Nov 15, 2026, ANDA 214749 (Vigabatrin), held by Upsher Smith Labs, was first approved by FDA on Jun 29, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2023
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VIGADRONE 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; VIGADRONE 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 3 submissions below

Date	Submission	Status	Documents
Jun 29, 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 4REMS	Approved	None posted
Sep 12, 2024	Supplement 1REMS	Approved	None posted
Jun 29, 2023	Original application	Approved	REMS

Identifiers

Application: ANDA 214749
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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