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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 Drugs
December 27, 2021
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems...
Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film drugs
July 20, 2021
Aquestive Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.
Xeris Pharma gets US FDA fast track designation for diazepam non-aqueous injection to treat acute repetitive seizures expresspharma
October 22, 2020
It was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome.
FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment drugs
January 14, 2020
Neurelis, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizure
Proprietary Nasal Delivery Formulation of Diazepam Developed by Particle Sciences Reaches NDA contractpharma
November 12, 2018
Proprietary Nasal Delivery Formulation of Diazepam Developed by Particle Sciences Reaches NDA