FDA accepts Aquestive's NDA for Anaphylm; PDUFA date Jan 31, 2026

Aquestive Therapeutics, Inc.

FDA accepted NDA for Anaphylm (epinephrine oral film) to treat Type 1 allergic reactions, including anaphylaxis.
PDUFA target action date assigned as January 31, 2026; FDA may hold an Advisory Committee meeting.
If approved, Anaphylm would be first and only orally delivered epinephrine option in the U.S.
Product is a thin, device-free film that requires no special storage, fitting in wallet or pocket.

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