> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# No Committee for Aquestive’s Anaphylm
- URL: https://www.fdaweb.com/no-committee-for-aquestives-anaphylm/
- Published: 2025-09-04T12:00:00.000Z
- Updated: 2026-09-14T15:20:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159814

FDA has said it does not plan to convene an advisory committee to discuss the Aquestive Therapeutics NDA for its Anaphylm (dibutepinephrine) sublingual film to treat severe allergic reactions. A company [statement](https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-will-not-require-advisory?ref=fdaweb.com) says the PDUFA action date for the NDA remains 1/31/2026.

The company says Anaphylm is a polymer matrix-based prodrug product candidate that has the potential to be the first FDA-approved non-invasive, orally delivered epinephrine product to treat severe allergic reactions, including anaphylaxis.