Aquestive announces FDA acceptance of NDA, PDUFA date for Anaphylm

Aquestive Therapeutics (AQST) announced that the U.S. Food and Drug Administration, FDA, has accepted the Company’s New Drug Application, NDA, for Anaphylm in the treatment of Type 1 allergic reactions, including anaphylaxis, and has assigned a Prescription Drug User Fee Act, PDUFA, target action date of January 31, 2026. The FDA reiterated that it may decide to conduct an Advisory Committee meeting for the approval of Anaphylm. If approved by the FDA, Anaphylm would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States.