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Vigabatrin - sanofi-aventis

Drug Profile

Vigabatrin - sanofi-aventis

Alternative Names: Gamma-vinyl-GABA; GVG; M071754; MDL 71754; RMI 71754; Sabril; Sabrilex; γ-vinyl-GABA

Latest Information Update: 05 Nov 2023

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Infantile spasms; Epilepsy
  • 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
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