PDUFA date for AV 001 a treatment for Narcolepsy, is extended to 15 December 2019-.- Avadel Pharma
Avadel Pharmaceuticals plc announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) Action Date relating to the New Drug Application (NDA) for AV 001, a sterile injectable product designed for use in the hospital setting, by three months to 15 December 2019. The NDA for AV 001 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.
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