Treats intermediate or high-risk primary or secondary (post-polycythemia vera or…. NDA 208712, held by Sobi. Pacritinib Citrate.
As of Nov 15, 2026, NDA 208712 (Vonjo), held by Sobi, was first approved by FDA on Feb 28, 2022, with 6 approved supplements and 0 published complete response letters.
VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VonjoEQ 100MG BASE · capsule;oral | Pacritinib Citrate | RxReference drug |
| Jul 20, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Mar 18, 2026 | Supplement 7Labeling · Standard review | Approved | |
| Oct 1, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Aug 22, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Nov 12, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Aug 15, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Feb 28, 2022 | Original applicationNew molecular entity · Priority 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
