NDA 206088, held by Celgene Corp. Apremilast.
As of Nov 14, 2026, NDA 206088 (Otezla), held by Celgene Corp, was first approved by FDA on Sep 23, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2014 | Original applicationNew indication · Standard review | Approved |
| Otezla10MG · tablet;oral | Apremilast | Rx |
| Otezla20MG · tablet;oral | Apremilast | Rx |
| Otezla30MG · tablet;oral | Apremilast | Rx |
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
