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A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder

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Trial Profile

A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms CEES
  • Sponsors Ironshore Pharmaceutical and Development

Most Recent Events

  • 14 Nov 2024 According to a Knight Therapeutics media release, Health Canada has approved JORNAY PM for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children from 6 to 12 years of age.
  • 09 Aug 2018 According to an Ironshore Pharmaceuticals and Development media release, the U.S. Food and Drug Administration has approved the New Drug Application for JORNAY PM for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 years and older. Ironshore plans to initiate the commercial launch of JORNAY PM in the first half of 2019.
  • 15 Dec 2016 According to Ironshore Pharmaceutical media release, U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for HLD200 in the treatment of Attention-Deficit/Hyperactivity Disorder and expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is July 30, 2017.

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