Anaphylm™ (dibutepinephrine) — NDA/BLA submission
Q4 2026
Aquestive continues to advance its ex-U.S. regulatory progress for Anaphylm and remains on track to complete its New Drug Submission to Health Canada in Q4 2026.Source filing
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AQUESTIVE THERAPEUTICS INC · Data as of 2026-10-25
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Anaphylm™ (dibutepinephrine) — PDUFA
Mar 16
Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a biopharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, in keeping with the FDA's classification of the resubmission as a Class 2 response.Source filing