Sodium oxybate - Jazz Pharmaceuticals

Drug Profile

Sodium oxybate - Jazz Pharmaceuticals

Alternative Names: Gamma-hydroxybutyrate; JZP-6; KEY-10; NSC-84223; Xyrem

Latest Information Update: 17 Jul 2018

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At a glance

  • Originator Jazz Pharmaceuticals
  • Developer Bausch Health Companies; Jazz Pharmaceuticals; Jazz Pharmaceuticals Inc; Jazz Pharmaceuticals plc; UCB
  • Class Butyric acids; Hydroxybutyrates; Sleep disorder therapies; Small molecules
  • Mechanism of Action Dopamine receptor agonists
  • Orphan Drug Status

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

    Yes - Narcolepsy; Cataplexy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cataplexy; Narcolepsy
  • Discontinued Essential tremor; Fibromyalgia

Most Recent Events

  • 13 Jul 2018 Valeant Pharmaceuticals International is now called Bausch Health Companies
  • 27 Jun 2018 FDA assigns PDUFA action date of 27/10/2018 for Sodium oxybate for Narcolepsy (In adolescents, In children)
  • 27 Jun 2018 US FDA accepts sNDA for Sodium oxybate for Narcolepsy (In adolescents, In children) for priority review
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