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Aquestive Therapeutics (AQST) Announces FDA Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant Buccal Film

December 21, 2021 5:15 AM EST

Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients unmet needs and solve therapeutic problems, announced today that, regarding the review of the New Drug Application (NDA) for Libervant (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters, the U.S. Food & Drug Administration (FDA) sent the following notice to the Company;

Please refer to your NDA 212641 Libervant resubmission dated June 23, 2021.

The purpose... More