Aquestive resubmits FDA NDA for Anaphylm after human factors, confirmatory PK studies

Aquestive Therapeutics resubmitted its FDA application for Anaphylm (dibutepinephrine) sublingual film to treat severe allergic reactions, including anaphylaxis.

The filing is backed by positive topline human factors and confirmatory PK study results already disclosed in August 2026.

Studies supported a revised package and instructions, showing easier, faster use with no protocol-defined self-administration errors.

FDA will classify the resubmission, setting the review timeline and next decision point for a potential U.S. launch.