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

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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: 17 Mar 2021

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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

  • 07 Oct 2020 According to an AcuCort media release, AcuCort AB has received the market approval from the Swedish Medical Products Agency for the drug ISICORT.This bioequivalence study forms the basis of the application for marketing approval in Europe and was carried out with positive results.
  • 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.

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