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# Aquestive Therapeutics NDA for Clobazam Oral Film
- URL: https://www.fdaweb.com/aquestive-therapeutics-nda-for-clobazam-oral-film/
- Published: 2018-01-18T12:00:00.000Z
- Updated: 2026-09-14T23:14:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140533

FDA has accepted for review an Aquestive Therapeutics NDA for clobazam oral soluble film (OSF) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. LGS accounts for about 4% of all cases of childhood epilepsy. The agency has set a user fee review action target for the third quarter.

Clobazam is administered using Aquestive’s proprietary PharmFilm drug delivery technology. It dissolves instantly after being placed on the tongue and can be administered without water, the company says.

The submission is based on two multicenter controlled studies were conducted to evaluate the bioequivalence of clobazam OSF with clobazam tablets, a benzodiazepine currently on market, at the same dosage strengths. Based on the studies, clobazam OSF was demonstrated to be bioequivalent to clobazam tablets and have comparable safety, Aquestive says.