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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2017

At a glance

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

    • 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.
    • 02 Oct 2015 According to a Highland Therapeutics media release, Ironshore Pharmaceuticals & Development will be presenting clinical data from this trial at the American Academy of Child and Adolescent Psychiatry
    • 02 Oct 2015 According to a Highland Therapeutics media release, Ironshore Pharmaceuticals & Development will be presenting clinical data from this trial at the Society for Developmental and Behavioral Pediatrics.
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