Posted by Michael Wonder on 22 Jun 2023
ARS Pharmaceuticals announces PDUFA date extension for neffy (intranasal epinephrine) for the treatment of allergic reactions (type 1), including anaphylaxis
20 June 2023 - Additional time needed for labelling and post-marketing requirements discussions; PDUFA date set for 19 September 2023.
ARS Pharmaceuticals today announced that the US FDA extended the PDUFA target action date by three months for the new drug application for neffy (intranasal epinephrinea/adrenaline) for the treatment of allergic reactions (type 1), including anaphylaxis, for adults and children ≥30kg.
