AQST - Aquestive receives FDA feedback; to resubmit marketing application for Libervant

Aquestive Therapeutics (AQST) announced that it received written feedback from the FDA regarding its New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.The guidance received from the regulator included the FDA’s expectations for the information and supporting analysis relating to the population pharmacokinetic model which the company expects to include in its upcoming resubmission of the NDA.“We have a clear path to resubmitting our NDA for Libervant and expect to do so around the end of the second quarter of 2021,” said Keith Kendall, President, and CEO of Aquestive.With a six-month review period following the resubmission, Aquestive expects an FDA action date in 2021.In September, the company announced that it received a complete response letter from the FDA regarding its marketing application for Libervant Buccal Film for management of seizure clusters.

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Aquestive receives FDA feedback; to resubmit marketing application for Libervant