AQUESTIVE (AQST) Resubmits Anaphylm NDA to FDA After January Rejection
Aquestive has refiled its application for the needle-free epinephrine film Anaphylm, backed by new human factors and pharmacokinetic data.
Aquestive Therapeutics (AQST) said on September 17, 2026 that it has resubmitted its New Drug Application to the FDA for Anaphylm (dibutepinephrine) sublingual film, its needle-free epinephrine product for Type I allergic reactions including anaphylaxis. The resubmission follows the Complete Response Letter the agency issued on January 30, 2026, and is supported by positive topline human factors and pharmacokinetic results announced in August 2026. The FDA will set the resubmission classification and review timeline after an initial review.
