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Libervant FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 1, 2022.

FDA Approved: No (Tentative Approval)
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

DateArticle
Sep 11, 2023Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) Date
Aug 31, 2022Aquestive Therapeutics Receives FDA Tentative Approval for Libervant (diazepam) Buccal Film
Dec 20, 2021Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant (diazepam) Buccal Film
Jul 19, 2021Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film
Jun 24, 2021Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film
Feb 25, 2021Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission For Libervant™ (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
Feb 10, 2020Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film
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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