pdufa.bio

LIBERVANT (diazepam)

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

LIBERVANT (diazepam) is an Eton Pharmaceuticals, Inc. program in seizure clusters, expansion to patients ages 6 to 11. Its PDUFA date is Mar 29, 2027, the FDA's goal date to complete review of the application. Every date links its source.

ETON catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Seizure clusters, expansion to patients ages 6 to 11. Sponsor: Eton Pharmaceuticals, Inc. (ETON). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Mar 29, 2027ETON

Specialist biotech funds holding ETON, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
EcoR1 Capital2,171,938$78.6 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is LIBERVANT (diazepam)'s next FDA decision or readout?

LIBERVANT (diazepam)'s PDUFA date is Mar 29, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at LIBERVANT (diazepam)'s most recent FDA decision?

No FDA decision for LIBERVANT (diazepam) is in our archive yet.

What is LIBERVANT (diazepam) used for?

In our records LIBERVANT (diazepam) is under review or in development for Seizure clusters, expansion to patients ages 6 to 11.

Who makes LIBERVANT (diazepam)?

Eton Pharmaceuticals, Inc. (ETON).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.