Aquestive Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Anaphylm™, a treatment for severe allergic reactions, including anaphylaxis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026, for the review of Anaphylm. If approved, Anaphylm will be the first and only orally delivered epinephrine option available in the United States, offering a device-free, easily portable alternative to current treatments. The FDA may also consider conducting an Advisory Committee meeting as part of the approval process. This development marks a significant step toward providing an innovative, user-friendly solution for managing life-threatening allergic reactions.
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