Treats intermediate or high-risk myelofibrosis (MF), including primary MF…. NDA 217180, held by Incyte Corp. Ruxolitinib Phosphate.
As of Nov 13, 2026, NDA 217180 (Jakafi Xr), held by Incyte Corp, was first approved by FDA on May 1, 2026, with 1 approved supplement and 0 published complete response letters.
JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Jakafi XrEQ 11MG BASE · tablet, extended release;oral | Ruxolitinib Phosphate | RxReference drug |
| Jakafi XrEQ 22MG BASE · tablet, extended release;oral | Ruxolitinib Phosphate | RxReference drug |
| Jakafi XrEQ 33MG BASE · tablet, extended release;oral | Ruxolitinib Phosphate | RxReference drug |
| Jakafi XrEQ 44MG BASE · tablet, extended release;oral | Ruxolitinib Phosphate | RxReference drug |
| Jakafi XrEQ 55MG BASE · tablet, extended release;oral | Ruxolitinib Phosphate | RxReference drug |
| Jul 20, 2026 | Supplement 1Labeling · Standard review | Approved | |
| May 1, 2026 | Original applicationNew formulation or manufacturer · 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
