FDA Accepts Aquestive Therapeutics’ Anaphylm NDA Resubmission; PDUFA Goal Action Date Set For March 16, 2027

Aquestive Therapeutics has announced that the FDA has accepted its resubmission of the New Drug Application (NDA) for Anaphylm, classifying it as a Class 2 response. The Prescription Drug User Fee Act (PDUFA) goal action date is set for March 16, 2027. The company plans to continue its ex-U.S. strategy with a Canadian New Drug Submission (NDS) planned for Q4 2026.