Treats active psoriatic arthritis. NDA 205437, held by Amgen Inc. Apremilast.
As of Nov 13, 2026, NDA 205437 (Otezla), held by Amgen Inc, was first approved by FDA on Mar 21, 2014, with 13 approved supplements and 0 published complete response letters.
OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis Plaque psoriasis who are candidates for phototherapy or systemic therapy Oral ulcers associated with Behçet's Disease Pediatric patients 6 years of age and older with: Active psoriatic arthritis Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2025 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Apr 25, 2024 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jul 20, 2023 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2021 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 19, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Otezla10MG · tablet;oral | Apremilast | RxReference drug |
| Otezla20MG · tablet;oral | Apremilast | RxReference drug |
| Otezla30MG · tablet;oral | Apremilast | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Jul 23, 2025 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Apr 25, 2024 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jul 20, 2023 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2021 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 19, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Dec 21, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Apr 27, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 19, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 28, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 22, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 21, 2014 | 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
