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Arcutis Biotherapeutics’ Subsidiary Arcutis Canada Secures Health Canada Approval For Roflumilast Cream In Pediatric Atopic Dermatitis Patients
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Health Canada approval of new 0.05% cream formulation expands the ZORYVE portfolio to include a once-daily, steroid-free option for younger children

  • The 0.05% formulation was specifically selected for young children, with clinical studies demonstrating significant improvements in disease severity as early as Week 1
  • Long-term extension study demonstrated a consistent safety profile through 56 weeks

TORONTO, Aug. 20, 2026 /CNW/ -- Arcutis Canada, Inc., a commercial stage company focused on delivering meaningful innovations in immuno-dermatology, today announced that Health Canada has approved PrZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis (AD) in pediatric patients 2 to 5 years of age.

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