LIBERVANT (diazepam buccal film) PDUFA date: FDA decision expected March 29, 2027
The FDA is expected to decide on LIBERVANT (diazepam buccal film) from Eton Pharmaceuticals, 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: EXHIBIT 99.1 PRESS RELEASE RELATING TO LIBERVANT LICENSING AGREEEMENT
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 LIBERVANT (diazepam buccal film)?
- The FDA's PDUFA target action date for LIBERVANT (diazepam buccal film) is March 29, 2027. The FDA can act before that date, and the review can be extended.
- What is LIBERVANT (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 LIBERVANT (diazepam buccal film)?
- Eton Pharmaceuticals, Inc. (ETON).
- 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).