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Epinephrine oral film - Aquestive Therapeutics

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Drug Profile

Epinephrine oral film - Aquestive Therapeutics

Alternative Names: Anaphylm; AQST-109; DESF Epinephrine; Epinephrine - Aquestive Therapeutics; Epinephrine SSF - Aquestive Therapeutics; Epinephrine sublingual film - Aquestive Therapeutics; Epinephrine sublingual soluble film - Aquestive Therapeutics

Latest Information Update: 23 Jun 2025

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At a glance

  • Originator MonoSol Rx
  • Developer Aquestive Therapeutics
  • Class Anti-infectives; Antiallergics; Antiasthmatics; Bronchodilators; Catecholamines; Ethanolamines; Skin disorder therapies; Small molecules
  • Mechanism of Action Alpha adrenergic receptor agonists; Beta adrenergic receptor agonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Anaphylaxis

Most Recent Events

  • 16 Jun 2025 FDA assigns PDUFA action date of January 31, 2026 for Epinephrine oral film for Anaphylaxis
  • 16 Jun 2025 The US FDA acceptes the New Drug Application (NDA) for Anaphylm™ in Anaphylaxis
  • 12 May 2025 Aquestive Therapeutics expects the US FDA to make an acceptance decision in the second quarter of 2025

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