Posted by Michael Wonder on 12 Aug 2019
Avadel Pharmaceuticals receives new PDUFA date for AV001 of 15 December 2019
8 August 2019 - PDUFA action extended 3 months; launch remains on track for 1Q 2020.
Avadel Pharmaceuticals today announced that the U.S. 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.
