The resubmission follows an FDA Complete Response Letter and cites human factors data showing pouch-opening time fell from 17 to 3 seconds.
News|Articles|September 21, 2026
Anaphylm Is Back at the FDA: A Clinician FAQ on Needle-Free Epinephrine
Author(s)Chelsie Derman
Fact checked by: Tim Smith
Aquestive has resubmitted its needle-free epinephrine film after an FDA rejection over usability, not efficacy. This FAQ covers what changed.
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On September 17, 2026, Aquestive Therapeutics resubmitted its New Drug Application (NDA) to the US Food & Drug Administration (FDA) for Anaphylm (dibutepinephrine) sublingual film, a needle-free epinephrine product for type I allergic reactions, including
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