Upcoming FDA decision · March 16, 2027
Anaphylm (dibutepinephrine) sublingual film PDUFA date: FDA decision expected March 16, 2027
151 days to goAquestive Therapeutics, Inc. (AQST) →
The FDA is expected to decide on Anaphylm (dibutepinephrine) sublingual film from Aquestive Therapeutics, Inc. in Type I allergic reactions, including anaphylaxis by the PDUFA target action date of March 16, 2027. For Type I allergic reactions, including anaphylaxis. NDA filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
March 16
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Anaphylm (dibutepinephrine) sublingual film?
- The FDA's PDUFA target action date for Anaphylm (dibutepinephrine) sublingual film is March 16, 2027. The FDA can act before that date, and the review can be extended.
- What is Anaphylm (dibutepinephrine) sublingual film being reviewed for?
- The application under FDA review covers Type I allergic reactions, including anaphylaxis.
- Which company is developing Anaphylm (dibutepinephrine) sublingual film?
- Aquestive Therapeutics, Inc. (AQST).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).