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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, recommended neffy approval based on current data set and without recommending additional trials FDA now requests repeat-dose study be completed prior […] The post FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application...
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epinephrine
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Posted: Sep 20 2023, 02:49
Author Name: forextv
Views: 091155