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
| Date | Article |
|---|
| Aug 31, 2022 | Aquestive Therapeutics Receives FDA Tentative Approval for Libervant (diazepam) Buccal Film |
| Dec 20, 2021 | Aquestive 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, 2021 | Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film |
| Jun 24, 2021 | Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film |
| Feb 25, 2021 | Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission For Libervant™ (Diazepam) Buccal Film Following FDA Feedback |
| Sep 25, 2020 | Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters |
| Feb 10, 2020 | Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film |
| Dec 2, 2019 | Aquestive 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, 2019 | Aquestive Therapeutics Completes Enrollment in Libervant (diazepam buccal film) Crossover Study |
Further information
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