Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027

Aquestive Therapeutics announced that the FDA has accepted its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for treating Type I allergic reactions and anaphylaxis. The FDA assigned a PDUFA goal date of March 16, 2027, classified as a Class 2 response. If approved, Anaphylm would be the first and only oral rescue medication for severe allergic reactions. The company is also advancing its Canadian regulatory submission planned for Q4 2026.