Treats active psoriatic arthritis. NDA 210745, held by Amgen Inc. Apremilast.
As of Nov 14, 2026, NDA 210745 (Otezla Xr, Otezla), held by Amgen Inc, was first approved by FDA on Aug 29, 2025, with 0 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.
| Aug 29, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved | |
| Aug 29, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Otezla Xr75MG · tablet, extended release;oral | Apremilast | RxReference drug |
| 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
