Lupin Gets USFDA Nod for Decitabine for Inj – CORPORATE ETHOS

Lupin Gets USFDA Nod for Decitabine for Inj

By: | November 15, 2018

Nov 15: Pharma major Lupin Ltd on Thursday announced that it has received approval for its Decitabine for Injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (USFDA).

“Lupin’s Decitabine for Injection, 50 mg/vial, Single-Dose Vial is the generic version of Otsuka’s Dacogen for Injection, 50 mg/vial, Single-Dose Vial. It is indicated for the treatment of 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,” the company said.

Decitabine for Injection, 50 mg/vial, Single-Dose Vial had annual sales of approximately $135.9 million in the US (IQVIA MAT September 2018).