Diazepam Buccal Film PDUFA date: FDA decision expected March 29, 2027
The FDA is expected to decide on Diazepam Buccal Film from Aquestive Therapeutics, Inc. in Seizure clusters / acute repetitive seizures in patients with epilepsy, label expansion to ages 6 to 11 by the PDUFA target action date of March 29, 2027. For Seizure clusters / acute repetitive seizures in patients with epilepsy, label expansion to ages 6 to 11. 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.
Questions about this FDA decision
- When is the PDUFA date for Diazepam Buccal Film?
- The FDA's PDUFA target action date for Diazepam Buccal Film is March 29, 2027. The FDA can act before that date, and the review can be extended.
- What is Diazepam Buccal Film being reviewed for?
- The application under FDA review covers Seizure clusters / acute repetitive seizures in patients with epilepsy, label expansion to ages 6 to 11.
- Which company is developing Diazepam Buccal 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).