Avadel Pharmaceuticals Receives New PDUFA Date for AV001 of December 15, 2019
Avadel Pharmaceuticals plc - Ordinary Share (AVDL)
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Source: GlobeNewswire
DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218 for narcolepsy, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date relating to the New Drug Application (NDA) for AV001, a sterile injectable product designed for use in the hospital setting, by three months to December 15, 2019. The NDA for AV001 was originally accepted in May 2019 under the FDA’s Priority Review program with a statutory six-month review. This three-month extension relates to recent submissions Avadel made in response to FDA requests for additional analytical information. The FDA determined that these submissions constitute a major amendment and will require additional time to review. “We have remained in contact with the FDA since filing the AV001 NDA and look forward to continuing our constructive dialog with the Agency,” said Greg Divis, Chief Execu
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