Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy
Avadel Pharmaceuticals plc - Ordinary Share (AVDL)
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Source: GlobeNewswire
DUBLIN, Ireland, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, 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. “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, Chief Executive Officer of Avadel. “Once-at-bedtime FT218 has the potential to truly impact the way people with narcolepsy are able to live t
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