NDA 215309, held by Incyte Corp. Ruxolitinib Phosphate.
As of Nov 13, 2026, NDA 215309 (Opzelura), held by Incyte Corp, was first approved by FDA on Sep 21, 2021, with 4 approved supplements and 0 published complete response letters.
OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2025 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2022 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Sep 21, 2021 | Original applicationNew indication · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OpzeluraEQ 1.5% BASE · cream;topical | Ruxolitinib Phosphate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Sep 18, 2025 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 13, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Jul 18, 2022 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Sep 21, 2021 | Original applicationNew indication · Priority 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
