SNY - FDA Rejects EpiPen Alternative - ARS Pharmaceuticals' Allergic Reaction Nasal Spray | Benzinga
The FDA issued a Complete Response Letter regarding ARS Pharmaceuticals Inc's (NASDAQ: SPRY) New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis (fatal allergic reaction) for adults and children ≥30 kg.
ARS Pharma's Neffy is to be an alternative to EpiPen and other autoinjectors like Sanofi SA's (NASDAQ: SNY) Auvi-Q filled with epinephrine.
In the letter, the FDA requested the completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to ...