Posted by Michael Wonder on 02 Feb 2026
Aquestive Therapeutics announces FDA issuance of complete response letter for Anaphylm
2 February 2026 - Deficiencies limited to packaging and administration.
Aquestive Therapeutics today announced that it received a complete response letter from the US FDA on 30 January 2026 for the new drug application seeking approval of Anaphylm (dibutepinephrine) sublingual film for the treatment of type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more (approximately 66 pounds).
