Treats mild to moderate atopic dermatitis. NDA 219474, held by Acrotech Biopharma. Difamilast.
As of Nov 13, 2026, NDA 219474 (Adquey), held by Acrotech Biopharma, was first approved by FDA on Feb 12, 2026, with 0 approved supplements and 0 published complete response letters.
ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2026 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adquey1% · ointment;topical | Difamilast | RxReference drug |
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
