Treats plaque psoriasis. NDA 215272, held by Organon LLC. Tapinarof.
As of Nov 13, 2026, NDA 215272 (Vtama), held by Organon LLC, was first approved by FDA on May 23, 2022, with 1 approved supplement and 0 published complete response letters.
VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. 1.1 Plaque Psoriasis VTAMA cream is indicated for the topical treatment of plaque psoriasis in adults. 1.2 Atopic Dermatitis VTAMA cream is indicated for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
| Dec 12, 2024 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| May 23, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vtama1% · cream;topical | Tapinarof | 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
