olutasidenib
Drug Details
- Generic Name
- olutasidenib
- Brand Names
- REZLIDHIA
- Application Number
- NDA215814
- Sponsor
- Rigel Pharmaceuticals, Inc.
- NDC Codes
- 1
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- OLUTASIDENIB
Indications and Usage
1 INDICATIONS AND USAGE 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 [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )