Aquestive's needle-free epinephrine film gets March 2027 FDA decision date after rejection

Aquestive Therapeutics now has a fixed date for the commercial test of its lead asset. The US Food and Drug Administration has accepted a refiled application for Anaphylm, a dibutepinephrine film placed under the tongue, and will decide by 16 March 2027. The company disclosed the acceptance in a corporate presentation dated November 2026.

The refiling follows a complete response letter dated 30 January 2026, in which the agency declined to approve the product as first submitted. The material available does not say why the application was turned down or what Aquestive changed in the new filing. Nothing in it addresses likely sales, pricing or launch spending either, so the commercial value of an approval cannot be sized from this update.

As general context, resubmissions after a rejection of this kind usually carry a six-month review target, and the goal date is the point by which the agency aims to finish its assessment. It is a target, not a guarantee of approval.

The presentation also set out plans to seek clearance in Canada and the European Union, without giving timings. It covered two other programmes: AQST-108, an epinephrine gel for atopic dermatitis, and Libervant, a diazepam buccal film partnered with Eton. These are company-reported plans, not regulatory outcomes.