enasidenib mesylate
enasidenib mesylate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Idhifa. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- enasidenib mesylate
- Brand Names
- Idhifa
- Application Number
- NDA209606
- Sponsor
- Celgene Corporation
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ENASIDENIB MESYLATE
Indications and Usage
1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.