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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