The FDA informed the company that there are no information requests and will provide a new target action date as soon as possible.
"We have addressed all questions received to date and remain confident that the package we have submitted satisfies all of the FDA's requests. We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218," said Greg Divis, CEO of Avadel.
Related content: Benzinga's Full FDA Calendar.
Price Action: AVDL shares are down 14.9% at $8.50 during the premarket session on the last check Monday.
See more from Benzinga
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.