Rufinamide - Novartis

Drug Profile

Rufinamide - Novartis

Alternative Names: Banzel; CGP 33101; E 2080; Inovelon; RUF 331; SYN 111; Xilep™

Latest Information Update: 11 Jul 2018

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At a glance

  • Originator Novartis
  • Developer Biotie Therapies Corp.; Eisai Co Ltd
  • Class Amides; Antiepileptic drugs; Fluorobenzenes; Small molecules; Triazoles
  • Mechanism of Action Sodium channel antagonists
  • Orphan Drug Status

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

    Yes - Lennox-Gastaut syndrome
  • New Molecular Entity No

Highest Development Phases

  • Marketed Lennox-Gastaut syndrome
  • No development reported Epilepsy
  • Discontinued Generalised anxiety disorder; Neuropathic pain

Most Recent Events

  • 29 Jun 2018 Preregistration for Lennox-Gastaut syndrome (Adjunctive treatment, In adults, In children, In adolescents) in European Union (PO)
  • 29 Jun 2018 CHMP recommended change in terms of the MAA for Lennox-Gastaut syndrome in the European Union
  • 27 Jun 2018 Registered for Lennox-Gastaut syndrome (Adjunctive treatment, In adolescents, In adults, In children) in Australia (PO)
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