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# Aquestive Therapeutics NDA Resubmission Plans
- URL: https://www.fdaweb.com/aquestive-therapeutics-nda-resubmission-plans/
- Published: 2021-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:48:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148748

Aquestive Therapeutics says that feedback from FDA has put it on a “clear path” to resubmit its NDA for Libervant (diazepam) Buccal Film for managing seizure clusters. The further guidance from the agency addressed a revised weight-based dosing regimen, modeling and simulations data that Aquestive provided 12/2020, the company says. FDA’s written feedback provided direction on expectations for the information and supporting analysis relating to the company’s population pharmacokinetic model, it says.

Aquestive says it received a complete response letter 9/25/2020 and subsequently completed a Type A meeting with the agency 11/2020\. Based on the feedback at that time, the company says it continues to believe that no further clinical studies are necessary for the NDA resubmission. Once resubmitted, it expects a six-month review process.

Libervant is an inside-the-cheek-administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of anti-epileptic drugs who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive is developing Libervant as an alternative to Diastat (diazepam rectal gel), the current standard of care rescue therapy for these patients.