Aquestive: FDA Will Not Require an Advisory Committee Meeting for NDA for Anaphylm

 

• NDA remains on track for FDA PDUFA goal date of January 31, 2026
• Commercial planning continues enabling rapid launch following approval

Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film. The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.

Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue.

https://www.globenewswire.com/news-release/2025/09/04/3144314/0/en/Aquestive-Therapeutics-Announces-that-FDA-Will-Not-Require-an-Advisory-Committee-Meeting-to-Discuss-New-Drug-Application-for-Anaphylm.html