Treats chronic graft-versus-host disease (chronic GVHD) after failure of at least two…. NDA 214783, held by Kadmon Pharms LLC. Belumosudil Mesylate.
As of Nov 13, 2026, NDA 214783 (Rezurock), held by Kadmon Pharms LLC, was first approved by FDA on Jul 16, 2021, with 4 approved supplements and 0 published complete response letters.
REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RezurockEQ 200MG BASE · tablet;oral | Belumosudil Mesylate | RxReference drug |
| Jan 15, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Dec 30, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Apr 10, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Nov 9, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Jul 16, 2021 | 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
