Posted by Michael Wonder on 20 Sep 2023
FDA issues complete response letter for neffy (epinephrine nasal spray) new drug application with request for additional study
19 September 2023 - FDA Advisory Committee (PADAC), held in May 2023, recommended neffy approval based on current data set and without recommending additional trials.
ARS Pharmaceuticals today announced that the US FDA issued a complete response letter regarding its new drug application for neffy (epinephrine nasal spray) in the treatment of allergic reactions (Type I), including anaphylaxis for adults and children ≥30 kg.
