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Diazepam - Aquestive Therapeutics

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Drug Profile

Diazepam - Aquestive Therapeutics

Alternative Names: AQST-203; DBF; DBSF; Diazepam BSF; Diazepam buccal soluble film - Aquestive Therapeutics; Libervant

Latest Information Update: 13 Sep 2023

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At a glance

  • Originator MonoSol Rx
  • Developer Aquestive Therapeutics
  • Class Antiepileptic drugs; Anxiolytics; Benzodiazepines; Benzodiazepinones; Hypnosedatives; Muscle relaxants; Small molecules
  • Mechanism of Action GABA A receptor agonists
  • Orphan Drug Status

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

    Yes - Seizures
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Registered Seizures
  • Phase III Epilepsy

Most Recent Events

  • 11 Sep 2023 FDA assigns PDUFA action date of (28/04/2024) for diazepam for Seizures (In children)
  • 11 Sep 2023 US FDA accepts NDA for diazepam for Seizures (In children) for review
  • 29 Jun 2023 Aquestive Therapeutics files NDA for diazepam treatment of patients with Seizures (In children) in USA
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