Upcoming FDA decision · February 23, 2027
Roflumilast PDUFA date: FDA decision expected February 23, 2027
128 days to goArcutis Biotherapeutics, Inc. (ARQT) →
The FDA is expected to decide on Roflumilast from Arcutis Biotherapeutics, Inc. in Mild to moderate atopic dermatitis in infants aged 3 to 24 months by the PDUFA target action date of February 23, 2027. For Mild to moderate atopic dermatitis in infants aged 3 to 24 months. sNDA 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 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
February 23
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for Roflumilast?
- The FDA's PDUFA target action date for Roflumilast is February 23, 2027. The FDA can act before that date, and the review can be extended.
- What is Roflumilast being reviewed for?
- The application under FDA review covers Mild to moderate atopic dermatitis in infants aged 3 to 24 months.
- Which company is developing Roflumilast?
- Arcutis Biotherapeutics, Inc. (ARQT).
- 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).