ZORYVE cream 0.3% (roflumilast) PDUFA Date (Arcutis Biotherapeutics)
FDA PDUFA decision date for ZORYVE cream 0.3% (roflumilast) is June 29, 2026. Developed by Arcutis Biotherapeutics. Indication: Plaque psoriasis (children 2-5 years). Current status: Approved.
Indication
Plaque psoriasis (children 2-5 years)
Regulatory details
- Company: Arcutis Biotherapeutics
- Therapeutic area: Dermatology
- Application type: sNDA
- Review type: Standard
- PDUFA date: 2026-06-29
- Outcome: Approved