Lupin receives FDA nod for generic Dacogen
Lupin has received the Food and Drug Administration’s approval for decitabine for injection 50 mg/vial, single-dose vial.
The product is a generic version of Otsuka Pharmaceutical's Dacogen for injection 50 mg/vial, single-dose vial.
It is indicated for the treatment of patients with myelodysplastic syndromes, or 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 50 mg/vial, single-dose vial had a market value of approximately $135.9 million, according to September 2018 IQVIA data.
The product is a generic version of Otsuka Pharmaceutical's Dacogen for injection 50 mg/vial, single-dose vial.
It is indicated for the treatment of patients with myelodysplastic syndromes, or 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 50 mg/vial, single-dose vial had a market value of approximately $135.9 million, according to September 2018 IQVIA data.