Dexamethasone - oral dissolvable film - AcuCort

Drug Profile

Dexamethasone - oral dissolvable film - AcuCort

Alternative Names: Dexa-ODF

Latest Information Update: 27 Jun 2018

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At a glance

  • Originator AcuCort
  • Class Anti-inflammatories; Antiemetics; Antineoplastics; Fluorinated steroids; Glucocorticoids; Pregnadienetriols; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Phase I Unspecified
  • Clinical Phase Unknown Chemotherapy-induced nausea and vomiting; Croup; Hypersensitivity

Most Recent Events

  • 21 Jun 2018 AcuCort signs collaboration agreement with Quinta-Analytica to conduct bioequivalence studies of dexamethasone oral film for potential approval in USA and European Union for Hypersensitivity
  • 21 Jun 2018 AcuCort plans a meeting with US FDA for discussions related to prospective bioequivalence studies
  • 21 Jun 2018 AcuCort plans bioequivalence studies of dexamethasone oral film in the second half of 2018
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