Posted by Michael Wonder on 26 Sep 2020
Aquestive Therapeutics receives complete response letter from FDA for Libervant (diazepam) buccal film for management of seizure clusters
25 September 2020 - No additional clinical studies anticipated by Aquestive.
Aquestive Therapeutics announced today that the U.S. FDA has issued a complete response letter regarding the new drug application for Libervant (diazepam) buccal film for management of seizure clusters.
In the letter, the FDA cited that, in a study submitted by the Company with the new drug application, certain weight groups showed a lower drug exposure level than desired.
