MedPath

Vigabatrin

Generic Name
Vigabatrin
Brand Names
Sabril, Vigadrone, Kigabeq
Drug Type
Small Molecule
Chemical Formula
C6H11NO2
CAS Number
68506-86-5
Unique Ingredient Identifier
GR120KRT6K

Overview

Vigabatrin is an analog of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms. It irreversibly inhibits the enzyme responsible for GABA metabolism, thereby increasing levels of circulating GABA. Although administered as a racemic mixture, only the S(+) enantiomer is pharmacologically active. It was first introduced as an antiepileptic agent in the United Kingdom in 1989 and was used extensively until 1997, when an association with vision loss became apparent. Its use is now generally reserved for patients who have failed alternative therapies, and its US approval by the FDA in 2009 mandated the creation of a drug registry to monitor patients for visual deficits.

Indication

Vigabatrin is indicated as adjunctive therapy in the treatment of refractory complex partial seizures in patients 2 years of age and older who have had inadequate responses to multiple previous treatments (i.e. not to be used for first-line therapy). It is also indicated as monotherapy in the treatment of infantile spasms in patients between 1 month and 2 years of age for whom the potential benefits outweigh the risk of vision loss.

Associated Conditions

  • Infantile Spasms (IS)
  • Refractory Complex partial seizures

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dr. Reddys Laboratories Inc.,
43598-697
ORAL
50 mg in 1 mL
11/11/2021
Lupin Pharmaceuticals, Inc.
68180-521
ORAL
500 mg in 1 1
12/1/2022
Amneal Pharmaceuticals NY LLC
69238-1425
ORAL
500 mg in 1 1
12/30/2023
Actavis Pharma, Inc.
0591-3851
ORAL
500 mg in 1 1
3/31/2022
Upsher-Smith Laboratories, LLC
0245-0556
ORAL
50 mg in 1 mL
9/24/2020
Zydus Pharmaceuticals (USA) Inc.
70710-1287
ORAL
500 mg in 1 1
3/21/2024
Amneal Pharmaceuticals NY LLC
60219-1424
ORAL
500 mg in 1 1
4/27/2023
Actavis Pharma, Inc.
0591-3955
ORAL
50 mg in 1 mL
11/30/2022
Upsher-Smith Laboratories, LLC
0245-6001
ORAL
500 mg in 1 1
3/31/2023
Novadoz Pharmaceuticals LLC
72205-093
ORAL
50 mg in 1 mL
7/21/2020

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
9/20/2018

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SABRIL TABLET 500 mg
SIN07955P
TABLET, FILM COATED
500 mg
12/9/1994

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
SABRIL vigabatrin 0.5g powder oral sachetl
52985
Medicine
A
7/17/1995
SABRIL vigabatrin 500mg tablet blister pack
150021
Medicine
A
5/12/2008

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SABRIL
02065819
Tablet - Oral
500 MG
12/31/1994
SABRIL PWR 2G/SACHET
aventis pharma inc
02068001
Powder - Oral
2 G / PCK
N/A
SABRIL PWR 1G/SACHET
aventis pharma inc
02068028
Powder - Oral
1 G / PCK
N/A
SABRIL
02068036
Powder For Solution - Oral
500 MG / SACHET
8/20/1997
SABRIL PWR 3G/SACHET
aventis pharma inc
02067994
Powder - Oral
3 G / PCK
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
KIGABEQ 100 MG COMPRIMIDOS SOLUBLES
1181302001
COMPRIMIDO SOLUBLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
SABRILEX 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Sanofi Aventis S.A.
59361
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
KIGABEQ 500 MG COMPRIMIDOS SOLUBLES
1181302002
COMPRIMIDO SOLUBLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
VIGZIP 100 MG/ML SOLUCION ORAL
Ria Generics Limited
89567
SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
SABRILEX 500 mg GRANULADO PARA SOLUCION ORAL
Sanofi Aventis S.A.
59809
POLVO PARA SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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