Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001

Avadel Pharmaceuticals

22 May 2019 - AV001 granted priority review.

Avadel Pharmaceuticals today announced that the U.S. FDA has accepted the new drug application for the Company’s fourth hospital product, AV001.

The FDA has assigned a Prescription Drug User Fee Act target action date of 15 September 2019.

Read Avadel Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier