Sublingual film containing Dexmedetomidine PDUFA date: FDA decision expected November 14, 2026
The FDA is expected to decide on Sublingual film containing Dexmedetomidine from BioXcel Therapeutics, Inc. in At-home acute treatment of agitation associated with bipolar disorders or schizophrenia by the PDUFA target action date of November 14, 2026. For At-home acute treatment of agitation associated with bipolar disorders or schizophrenia. sNDA. Verified against the company announcement on 2026-10-16.
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: bioxceltherapeutics.gcs-web.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for Sublingual film containing Dexmedetomidine?
- The FDA's PDUFA target action date for Sublingual film containing Dexmedetomidine is November 14, 2026. The FDA can act before that date, and the review can be extended.
- What is Sublingual film containing Dexmedetomidine being reviewed for?
- The application under FDA review covers At-home acute treatment of agitation associated with bipolar disorders or schizophrenia.
- Which company is developing Sublingual film containing Dexmedetomidine?
- BioXcel Therapeutics, Inc. (BTAI).
- 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).