Complete Response Letter issued for Anaphylm

What this means

Anaphylm is a sublingual film designed to quickly deliver epinephrine for emergency treatment of severe allergic reactions. Today the FDA declined to approve Anaphylm, citing issues with the application that need to be addressed before it can move forward. This decision delays potential access to a needle-free alternative for patients at risk of life-threatening allergic reactions, leaving them reliant on existing injectable options for now.