FDA Issues Complete Response Letter for neffy ® (epinephrine nasal spray) New Drug Application with Request for Additional Study

Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions FDA Advisory Committee (PADAC), held in May 2023,...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news