The U.S. Food and Drug Administration has accepted Aquestive Therapeutics' resubmission of the New Drug Application for Anaphylm (dibutepinephrine) sublingual film as complete. The agency assigned a Prescription Drug User Fee Act goal date of March 16, 2027, classifying the response as Class 2. This follows positive human factors and pharmacokinetic study results submitted in September to address deficiencies from a January 2026 Complete Response Letter. If approved, Anaphylm would be the first oral rescue medication for severe allergic reactions. Aquestive Therapeutics is a biopharmaceutical company advancing medicines through innovative science and delivery technologies.
