02/02/2026
The FDA has declined Anaphylm's application for approval, at least at this stage. We know many of you are interested in this under-the-tongue epinephrine film, so read our article for details: https://www.allergicliving.com/2026/02/02/fda-declines-epinephrine-films-approval-calls-for-usability-study/
The FDA's turndown could be more of a delay. The regulator wants further study of real-world usability to show that patients can manage correct placement of the product and opening of the pouch. Aquestive, the manufacturer, expresses confidence it can meet these requirements and resubmit its application by fall.