olutasidenib

FDA Drug Profile — REZLIDHIA

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 )