FDA grants tentative approval to Sypmazan oral film to treat Lennox-Gastaut Syndrome. - Aquestive Therapeutics, Inc.
Aquestive Therapeutics, Inc. announced that Sympazan (clobazam) oral film has received tentative approval by the FDA, for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. Currently, clobazam is marketed as ONFI and offered in two formulations - either tablet or oral suspension.
Final FDA approval for Sympazan is pending the expiration of the orphan drug exclusivity period for ONFI, which is expected in October 2018.
Comment: MonoSol RX changed its name to Aquestive Therapeutics, Inc. in November 2017.
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