Posted by Michael Wonder on 11 Feb 2020
Aquestive Therapeutics announces U.S. FDA filing acceptance of new drug application for Libervant (diazepam) buccal film
10 February 2020 - Assigned Prescription Drug User Fee Act goal date of 27 September 2020.
Aquestive Therapeutics announced today that, as anticipated, the U.S. FDA accepted the Company’s new drug application for Libervant (diazepam) Buccal Film for the management of seizure clusters.
If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients. Libervant was designated by the FDA as an orphan drug in November 2016.
