Vigabatrin

For refractory complex partial seizures. ANDA 208218, held by Ph Health. Vigabatrin.

As of Nov 15, 2026, ANDA 208218 (Vigabatrin), held by Ph Health, was first approved by FDA on Apr 27, 2017, with 13 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2017
Review: Standard
Supplements approved: 13
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 14 submissions below

Date	Submission	Status	Documents
Apr 27, 2017	Original application	Approved	REMS Letter

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 16REMS	Approved	None posted
Sep 12, 2024	Supplement 15REMS	Approved	None posted
Oct 11, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Oct 11, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Oct 12, 2022	Supplement 13REMS	Approved	None posted
Oct 2, 2020	Supplement 11REMS	Approved	None posted
Apr 17, 2020	Supplement 9REMS	Approved	None posted
Mar 12, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Mar 12, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Mar 12, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 12, 2019	Supplement 7REMS	Approved	None posted
May 30, 2019	Supplement 4REMS	Approved	None posted
Oct 23, 2017	Supplement 2REMS	Approved	None posted
Apr 27, 2017	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 208218
Drugs@FDA: Overview at FDA
Company: PH Health

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