Treats mild to moderate atopic dermatitis. NDA 207695, held by Anacor Pharms Inc. Crisaborole.
As of Nov 13, 2026, NDA 207695 (Eucrisa), held by Anacor Pharms Inc, was first approved by FDA on Dec 14, 2016, with 5 approved supplements and 0 published complete response letters.
EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.
| Apr 3, 2023 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2020 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2016 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Eucrisa2% · ointment;topical | Crisaborole | RxReference drug |
| Apr 3, 2023 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Mar 23, 2020 | Supplement 9Labeling · Standard review | Approved | |
| Mar 23, 2020 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Oct 16, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Dec 14, 2016 | Original applicationNew molecular entity · 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
