decitabine
Drug Details
- Generic Name
- decitabine
- Brand Names
- Decitabine, DECITABINE, decitabine
- Application Number
- ANDA206033
- Sponsor
- Amneal Pharmaceuticals LLC
- NDC Codes
- 10
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, KIT
- Routes
- INTRAVENOUS
- Active Ingredients
- DECITABINE
Indications and Usage
1 INDICATIONS AND USAGE Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1,intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation , and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. ( 1 )