Vigabatrin

For refractory complex partial seizures. ANDA 213519, held by Annora Pharma. Vigabatrin.

As of Nov 15, 2026, ANDA 213519 (Vigabatrin), held by Annora Pharma, was first approved by FDA on Jan 26, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2021
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vigabatrin for oral solution 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; vigabatrin for oral solution 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 4 submissions below

Date	Submission	Status	Documents
Jan 26, 2021	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vigabatrin500MG/PACKET · for solution;oral	Vigabatrin	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 12, 2024	Supplement 4REMS	Approved	None posted
Oct 25, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Oct 12, 2022	Supplement 2REMS	Approved	None posted
Jan 26, 2021	Original application	Approved	REMS

Identifiers

Application: ANDA 213519
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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