AQUESTIVE (AQST) Resubmits Anaphylm NDA to FDA After January Rejection
Aquestive Therapeutics has refiled its New Drug Application for Anaphylm sublingual epinephrine film after completing the human factors and PK studies the FDA demanded.
Aquestive Therapeutics (AQST) said it has resubmitted its New Drug Application to the U.S. Food and Drug Administration for Anaphylm (dibutepinephrine) sublingual film, its needle-free treatment for Type I allergic reactions including anaphylaxis. The filing follows a Complete Response Letter issued on January 30, 2026, and is supported by topline human factors and pharmacokinetic results the company announced in August. The FDA will determine the classification of the resubmission and set a review timeline after an initial review.