Lupin receives US FDA approval

Lupin has received approval for its Decitabine for Injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (FDA) to market a generic version of Otsuka Pharmaceutical (Otsuka) Dacogen for Injection, 50 mg/vial, Single-Dose Vial.

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 anaemia, refractory anaemia with ringed sideroblasts, refractory anaemia 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 annual sales of approximately $ 135.9 million in the US.

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