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# Aquestive’s NDA Resubmission Accepted for Review
- URL: https://www.fdaweb.com/aquestives-nda-resubmission-accepted-for-review/
- Published: 2026-10-15T19:33:33.000Z
- Updated: 2026-10-15T19:33:33.000Z
- Author: David McFarland
- Tags: Drugs

FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis. The agency has set a review action target date of 3/16/2027.

In January, FDA issued the company a complete response letter (CRL) on the original NDA that identified concerns in the product’s human factors validation study, including difficulty opening the pouch and incorrect placement of the sublingual film, which the agency said could pose safety risks during an anaphylactic emergency, according to the company. It also cited deficiencies involving packaging and administration. FDA did not raise chemistry, manufacturing, and controls issues and did not question the comparability data included in the application, it says.

In response to the CRL, Aquestive says it completed a human factors study evaluating revised packaging that incorporated modifications to the pouch opening, instructions for use, and pouch and carton labeling. It also completed a confirmatory PK study in healthy volunteers using the revised packaging and revised instructions for use, which evaluated self-administration and clinician administration of Anaphylm and included manual intramuscular epinephrine as a comparator. “No protocol-defined use errors were observed in the self-administration arm of the PK study,” it says.

Anaphylm is being developed as a non-invasive alternative to epinephrine auto-injectors for patients weighing at least 30 kilograms, according to the company. If approved, Anaphylm would be the first orally delivered, non-invasive epinephrine therapy for treating severe, life-threatening allergic reactions, including anaphylaxis.