Posted by Michael Wonder on 11 Sep 2023
Aquestive Therapeutics receives FDA acceptance of new drug application for Libervant (diazepam) buccal film in paediatric patients and assignment of PDUFA date
11 September 2023 - PDUFA target goal date set for 28 April 2024.
Aquestive Therapeutics today announced acceptance by the US FDA of the Company’s NDA for Libervant (diazepam) buccal film in paediatric patients between two and five years of age and the assignment of a PDUFA goal date of 28 April 2024.
