Treats relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate…. NDA 215814, held by Rigel Pharms. Olutasidenib.
As of Nov 13, 2026, NDA 215814 (Rezlidhia), held by Rigel Pharms, was first approved by FDA on Dec 1, 2022, with 0 approved supplements and 0 published complete response letters.
Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rezlidhia150MG · capsule;oral | Olutasidenib | RxReference drug |
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
