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Study evaluating action of ET-400

Trial Profile

Study evaluating action of ET-400

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2025

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At a glance

  • Drugs Hydrocortisone (Primary)
  • Indications Adrenal insufficiency; Endocrine disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Eton Pharmaceuticals

Most Recent Events

  • 06 Feb 2025 According to Eton pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for ET-400. The new PDUFA goal date is May 28, 2025.
  • 09 May 2024 According to Eton pharmaceuticals media release, R&D expenses for the first quarter of 2024 were $0.7 million compared to $0.5 million in the prior year period due to increased development costs associated with ET-400 and other products in the Company R&D pipeline. While the Company expects an increase in second quarter R&D expenses with a $2.0 million ET-400 filing fee, R&D spend for 2024 is forecasted to be approximately $4.0 million excluding the one-time filing fee.
  • 30 Apr 2024 According to Eton pharmaceuticals media release, the company Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400 and expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.

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