Vigabatrin - sanofi-aventis
Alternative Names: Gamma-vinyl-GABA; GVG; M071754; MDL 71754; RMI 71754; Sabril; Sabrilex; γ-vinyl-GABALatest Information Update: 05 Nov 2023
At a glance
- Originator sanofi-aventis
- Developer Alfresa Pharma Corporation; Lundbeck Inc; National Institute on Drug Abuse; Sanofi; sanofi-aventis
- Class Aminobutyric acids; Antiepileptic drugs; Drug withdrawal therapies; Small molecules
- Mechanism of Action 4-aminobutyrate transaminase inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Complex partial epilepsy; Epilepsy; Infantile spasms
- Discontinued Cocaine-related disorders; Substance-related disorders
Most Recent Events
- 27 Jan 2020 The US FDA approves label expansion for vigabatrin for adjunctive treatment of Complex partial epilepsy in children 2 to 10 years of age in USA
- 08 Aug 2019 Launched for Infantile spasms in Japan, prior August 2019 (PO)
- 23 Jun 2016 The US FDA approves the modified Risk Evaluation and Mitigation Strategy (REMS) for vigabatrin