Methylphenidate modified release - Highland Therapeutics

Drug Profile

Methylphenidate modified release - Highland Therapeutics

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

Latest Information Update: 13 Aug 2018

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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

  • Registered Attention-deficit hyperactivity disorder

Most Recent Events

  • 09 Aug 2018 Registered for Attention-deficit hyperactivity disorder (In children) in USA (PO)
  • 09 Aug 2018 Ironshore Pharmaceuticals intends to launch methylphenidate modified release in first half of 2019
  • 12 Jul 2018 US FDA assigns PDUFA action date of (08/08/2018) for methylphenidate for Attention-deficit hyperactivity disorder (ADHD)
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