Jun 26, 2025 · Key Takeaways Roflumilast cream 0.15% is recommended for mild to moderate AD in adults, reducing pruritus and disease severity safely. The cream is the first FDA-approved topical …

Jun 6, 2025 · Investigational ZORYVE (roflumilast) cream 0.05% for the topical treatment of mild to moderate AD in children 2 to 5 years old is under review by the FDA with a Prescription Drug User Fee …

Draft Guidance on Roflumilast May 2025 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish …

Additional Inclusion Criteria – Select If Applicable For patients who are pregnant or plan to become pregnant: Counseling provided on potential risks vs benefits of treatment and patient informed that it …

Oct 8, 2025 · Pronunciation: zor-EEV Generic name: roflumilast topical Dosage form: cream (0.05%, 0.15%, 0.3%), foam (0.3%) Drug class: Topical antipsoriatics Medically reviewed by Melisa Puckey, …

Oct 30, 2025 · ZORYVE cream 0.05% is a once-daily, steroid-free topical treatment that provides long-term disease control with no limitation on duration of use. In clinical trials, ZORYVE cream 0.05% had …

Jun 17, 2025 · The workgroup developed strong recommendations for the use of tapinarof cream, roflumilast cream, lebrikizumab, and nemolizumab with concomitant topical therapy.

References: 1. ZORYVE ® foam. Prescribing information. Arcutis Biotherapeutics, Inc; 2025. 2. ZORYVE ® cream. Prescribing information. Arcutis Biotherapeutics, Inc; 2025. 3. Osborne DW. Diethylene …

Dec 1, 2025 · Topical roflumilast, a potent phosphodiesterase-4 inhibitor, was recently approved for the treatment of plaque psoriasis, seborrheic dermatitis, and atopic dermatitis. By reducing cyclic …

Dec 3, 2025 · The drug was designed as a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor. The November 17 announcement by Arcutis Biotherapeutics, Inc. highlighted a …