Aquestive Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for Anaphylm™ (dibutepinephrine), a sublingual film for treating severe allergic reactions. The FDA has set a target action date, providing a clear regulatory timeline for the potential approval of what could be the first oral rescue medication for anaphylaxis.
Key Details
- Drug Candidate: Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis.
- Regulatory Milestone: The FDA accepted the NDA resubmission as complete and set a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027.
- Submission Context: The application was resubmitted on September 16, 2026, to address issues raised in an FDA Complete Response Letter from January 30, 2026.
- International Plans: The company remains on track to submit a New Drug Submission to Health Canada in Q4 2026.