Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027
Key Highlights
- ➤FDA accepted Anaphylm NDA resubmission as complete, classifying it as a Class 2 response
- ➤PDUFA goal date set for March 16, 2027
- ➤Canadian New Drug Submission remains planned for Q4 2026
- ➤Anaphylm could become the first oral rescue medication for anaphylaxis if approved
Expert Statements
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“The FDA’s acceptance of our resubmission and the assignment of a Class 2 PDUFA date as expected gives us a clear path forward for Anaphylm”
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“For decades, people at risk of anaphylaxis have had limited treatment options. Anaphylm, if approved, would represent a new level of innovation designed to comprehensively address patient needs, with the goal of providing patients and caregivers with an epinephrine treatment they can carry and use confidently, whether at school, at work, or while traveling.”
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“We look forward to working closely with the FDA to efficiently complete the review of our submission on or before our assigned goal date”
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“We believe Anaphylm has the potential to be an important new treatment option for patients and caregivers, and we are focused on making Anaphylm available as quickly as possible, if approved. In parallel, we are advancing our commercial preparations so that we are ready for the potential launch of Anaphylm, if approved.”
* FDA accepted the resubmission as complete and classified it as a Class 2 response * Prescription Drug User Fee Act (PDUFA) goal action date set for March 16, 2027 * Ex-U.S. strategy remains on track with Canadian NDS planned for Q4 2026 WARREN, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) -- 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. If approved, Anaphylm would be the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis.
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