Amantadine controlled-release - Adamas

Drug Profile

Amantadine controlled-release - Adamas

Alternative Names: ADS-5101; ADS-5102; amantadine ER; amantadine HCl; amantadine HCl extended release; Nurelin

Latest Information Update: 10 Jan 2017

Price : $50

At a glance

  • Originator Adamas Pharmaceuticals
  • Class Adamantanes; Antiparkinsonians; Antivirals; Organic bridged compounds; Small molecules
  • Mechanism of Action Dopamine receptor agonists; NMDA receptor antagonists
  • Orphan Drug Status

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

    Yes - Drug-induced dyskinesia
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No
  • Available For Licensing Yes - Dyskinesias

Highest Development Phases

  • Preregistration Drug-induced dyskinesia
  • Phase II Movement disorders
  • Discontinued Brain injuries

Most Recent Events

  • 10 Jan 2017 Adamas Pharmaceuticals accepts NDA for amantadine for Drug-induced Dyskinesia for review
  • 10 Jan 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Drug-induced dyskinesia in USA (PO) is 2017-08-24
  • 27 Oct 2016 Preregistration for Drug-induced dyskinesia in USA (PO) in October 2016
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