Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new drug application for FT218 is still on-going, and action will likely not be taken in October.
The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.
