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Bioequivalence Study for the EU to Compare Dexa ODF with Previously Approved Reference Drug Containing the Active Substance Dexamethasone

Trial Profile

Bioequivalence Study for the EU to Compare Dexa ODF with Previously Approved Reference Drug Containing the Active Substance Dexamethasone

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Sep 2019

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At a glance

  • Drugs Dexamethasone (Primary) ; Dexamethasone
  • Indications Chemotherapy-induced nausea and vomiting; Croup; Hypersensitivity
  • Focus Pharmacokinetics; Registrational
  • Sponsors AcuCort
  • Most Recent Events

    • 04 Sep 2019 According to an AcuCort media release, the company have adjusted the strategy for applying for ISICORT (previously called Dexa ODF) market approval in the EU to ensure the fastest possible approval.The registration process begins with a national hybrid application in Sweden and, after approval there, is followed by an application in several EU countries via the so-called Mutual Recognition Process (MRP).
    • 05 Mar 2019 According to an AcuCort media release, the date for the planned submission of the application for product approval by the allergy drug Dexa ODF in the EU will be moved from the second to the third quarter of 2019. This is because of the regulatory authoritys requirement for 12-month stability data for the product candidate.This means that the earliest possible opportunity for approval in the EU will be postponed until 2020.
    • 05 Mar 2019 Status changed to completed, according to an AcuCort media release.
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