Amantadine extended release - Osmotica Pharmaceutical

Drug Profile

Amantadine extended release - Osmotica Pharmaceutical

Alternative Names: Amantadine HCl Extended Release Tablets - Osmotica Pharmaceutical; OS-320; Osmolex ER

Latest Information Update: 24 Jul 2015

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At a glance

  • Originator Osmotica Pharmaceutical
  • Class Adamantanes; Antiparkinsonians; Antivirals; Organic bridged compounds; Small molecules
  • Mechanism of Action Dopamine receptor agonists; Dopamine release stimulants; 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
  • New Molecular Entity No

Highest Development Phases

  • Phase III Drug-induced dyskinesia

Most Recent Events

  • 22 Jul 2015 Amantadine extended release - Osmotica Pharmaceutical receives Orphan Drug status for Drug-induced dyskinesia in USA
  • 08 Jul 2015 Osmotica Pharmaceutical announces intention to submit NDA to the US FDA in 2016
  • 01 Jun 2014 Phase-III clinical trials in Drug-induced dyskinesia in France, Germany and Spain (PO)
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