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A Bioequivalence Bridging Study for Cotempla XR-ODT (Methylphenidate Extended-Release Orally Disintegrating Tablet)

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Trial Profile

A Bioequivalence Bridging Study for Cotempla XR-ODT (Methylphenidate Extended-Release Orally Disintegrating Tablet)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Aug 2016

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Pharmacokinetics

    • Most Recent Events

    • 18 Aug 2016 New trial record
    • 28 Jul 2016 According to a Neos Therapeutics media release, the company will re-submit the New Drug Application to the FDA for Cotempla XR-ODT by the end of this year and the anticipated marketing approval in time for the 2017.
    • 28 Jul 2016 According to a Neos Therapeutics media release, on November 6, 2015, the company has received a complete response letter by the U.S. Food and Drug Administration (FDA) requiring the company to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and the to-be-marketed commercial scale drug product, including an assessment of food effect, and to provide validation and three months of stability data.

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