FDA Accepts Aquestive Therapeutics’ Anaphylm NDA Resubmission; PDUFA Goal Action Date Set For March 16, 2027
FDA accepted the resubmission as complete and classified it as a Class 2 responsePrescription Drug User Fee Act (PDUFA) goal action date set for March 16, 2027Ex-U.S. strategy remains on track with Canadian NDS planned
Aquestive's medicine for severe allergic reactions passed the first FDA review step. Now the company waits until March 2027 for the final decision on approval.
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