Posted by Michael Wonder on 25 Jun 2021
Aquestive Therapeutics resubmits new drug application for Libervant (diazepam) buccal film
24 June 2021 - Anticipates FDA PDUFA goal date in late 2021.
Aquestive Therapeutics announced today the resubmission of its new drug application to the U.S. FDA for Libervant (diazepam) buccal film for the management of seizure clusters in response to the 25 September 2020 complete response letter from the FDA.
The submission included additional statistical modelling and supporting analyses of the existing clinical data based upon the guidance received from the Agency.
