Aquestive Therapeutics Receives FDA's Preliminary Comments on Anaphylm

 

• Reaffirms guidance to resubmit the Anaphylm NDA in Q3 2026
• Received clarifying feedback from the FDA on pharmacokinetic (PK) and human factor (HF) study designs
• Final FDA meeting minutes expected by early May 2026

https://www.globenewswire.com/news-release/2026/03/30/3264495/0/en/Aquestive-Therapeutics-Announces-Completion-of-Type-A-Meeting-with-FDA-for-Anaphylm-dibutepinephrine-Sublingual-Film.html