Treats seborrheic dermatitis. NDA 217242, held by Arcutis. Roflumilast.
As of Nov 13, 2026, NDA 217242 (Zoryve), held by Arcutis, was first approved by FDA on Dec 15, 2023, with 2 approved supplements and 0 published complete response letters.
ZORYVE topical foam, 0.3%, is a phosphodiesterase 4 inhibitor indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. 1.1 Seborrheic Dermatitis
| May 22, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 15, 2023 | Original applicationTYPE 3/4 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoryve0.3% · foam;topical | Roflumilast | RxReference drug |
| May 22, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2024 | Supplement 2Manufacturing | Approved | |
| Dec 15, 2023 | Original applicationTYPE 3/4 · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
