Methylphenidate modified release - Highland Therapeutics

Drug Profile

Methylphenidate modified release - Highland Therapeutics

Alternative Names: Benjorna; HLD-200; Methylphenidate delayed release; Methylphenidate hydrochloride extended release

Latest Information Update: 06 Jun 2017

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At a glance

  • Originator Highland Therapeutics
  • Developer Highland Therapeutics; Ironshore Pharmaceutical and Development
  • Class Phenylacetates; Piperidines; Sleep disorder therapies; Small molecules
  • Mechanism of Action Adrenergic receptor modulators; Central nervous system stimulants; Dopamine release stimulants
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Attention-deficit hyperactivity disorder

Most Recent Events

  • 23 May 2017 Post-hoc analysis data from a phase III trial in Attention-deficit hyperactivity disorder released by Ironshore Pharmaceuticals
  • 15 Dec 2016 Preregistration for Attention-deficit hyperactivity disorder in USA (PO)
  • 15 Dec 2016 Planned Prescription Drug User Fee Act (PDUFA) date for Attention-deficit hyperactivity disorder (In children) in USA (PO) is 2017-07-30
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