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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: 02 Nov 2018

At a glance

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

    • 02 Nov 2018 According to an Aquestive Therapeutics media release, the U.S. Food and Drug Administration (FDA) approved SYMPAZAN (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
    • 04 Sep 2018 Aquestive received tentative approval for Sympazan (clobazam) oral film for the treatment of Lennox-Gastaut Syndrome (LGS) from the U.S. Food and Drug Administration (FDA) in line with its assigned Prescription Drug User Fee Act (PDUFA) date of August 31, 2018. Final FDA approval for Sympazan is pending the expiration of the orphan drug exclusivity period for ONFI, which is expected in October 2018.
    • 24 Jan 2018 New trial record
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