ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)
In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
- In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
- ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
- In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
- ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.