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Libervant FDA Approval History

Last updated by Judith Stewart, BPharm on May 1, 2024.

FDA Approved: Yes (First approved April 26, 2024)
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 benzodiazepine diazepam that may be given to treat children aged 2 to 5 years with seizure clusters (also known as “acute repetitive seizures”) that are different from their usual seizure pattern.

Development timeline for Libervant

DateArticle
Apr 29, 2024Approval FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years
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

See also

Libervant (diazepam) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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