ARS Pharmaceuticals submits response to FDA's CRL for epinephrine nasal spray NDA, addressing PK/PD study and nitrosamine testing, initiating a 6-month FDA review.
ARS Pharmaceuticals has submitted its response to the FDA's Complete Response Letter (CRL) for its NDA of neffy® (epinephrine nasal spray) for treating Type I allergic reactions, including anaphylaxis. The response addresses the FDA's requests for a repeat dose pharmacokinetic/pharmacodynamic (PK/PD) study under nasal allergen challenge (NAC) conditions and updated nitrosamine testing per the FDA's August 2023 guidance. The submission has triggered a six-month review period by the FDA.
April 03, 2024
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