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Libervant FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 9, 2019.

FDA Approved: No
Brand name: Libervant
Generic name: diazepam
Dosage form: Buccal Film
Company: Aquestive Therapeutics, Inc.
Treatment for: Seizure Clusters

Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.

Development Timeline for Libervant

Feb 25, 2021Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission For Libervantâ„¢ (Diazepam) Buccal Film Following FDA Feedback
Sep 25, 2020Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters
Dec  2, 2019Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant (diazepam) Buccal Film for Management of Seizure Clusters
Jun  4, 2019Aquestive Therapeutics Completes Enrollment in Libervant (diazepam buccal film) Crossover Study

Further information

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