Second multicenter controlled bioequivalence study of clobazam oral soluble film (OSF) with clobazam tablets

Trial Profile

Second multicenter controlled bioequivalence study of clobazam oral soluble film (OSF) with clobazam tablets

Completed
Phase of Trial: Phase I

Latest Information Update: 24 Jan 2018

At a glance

  • Drugs Clobazam (Primary) ; Clobazam
  • Indications Lennox-Gastaut syndrome
  • Focus Pharmacokinetics; Registrational
  • Sponsors Aquestive Therapeutics
  • Most Recent Events

    • 24 Jan 2018 New trial record
    • 18 Jan 2018 According to a Aquestive Therapeutics media release, U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application for clobazam Oral Soluble Film (clobazam OSF) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older.The PDUFA (Prescription Drug User Fee Act) target date for completion of the FDA review is the third-quarter of 2018.
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