BRIEF—FDA accepts NDA for Aquestive’s Anaphylm

17 June 2025

Aquestive Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Anaphylm sublingual epinephrine film under development as a treatment of Type 1 allergic reactions, including anaphylaxis, for review.

The agency has assigned a PDUFA (Prescription Drug User Fee Act) target action date of January 31, 2026.

The company note that Anaphylm has the potential to become the first and only FDA-approved no-needle, no-device oral epinephrine option for treating severe allergic reactions in the USA.

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