Treats intermediate-2 or high-risk primary or secondary (post-polycythemia vera or…. NDA 212327, held by Bristol-Myers. Fedratinib Hydrochloride.
As of Nov 13, 2026, NDA 212327 (Inrebic), held by Bristol-Myers, was first approved by FDA on Aug 16, 2019, with 7 approved supplements and 0 published complete response letters.
INREBIC is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| InrebicEQ 100MG BASE · capsule;oral | Fedratinib Hydrochloride | RxReference drug |
| Jul 20, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Mar 18, 2026 | Supplement 9Labeling · Standard review | Approved | |
| May 12, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jul 30, 2024 | Supplement 6Labeling · Standard review | Approved | |
| May 15, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Dec 3, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Nov 23, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Aug 16, 2019 | 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
