FDA Denies Approval of Neffy, Nasal Spray Alternative to EpiPens for Anaphylaxis Treatment

2023-09-21 5

The U.S. Food and Drug Administration recently denied approval for Neffy, a needle-free epinephrine nasal spray designed as an alternative to EpiPens for treating anaphylaxis. Although the drug was approved for use in adults and children, the FDA requested additional data from ARS Pharmaceuticals before reconsidering the decision. The drugmaker plans to appeal the decision and resubmit its application in 2024.