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Lupin receives FDA approval for Decitabine for Injection, 50 mg/vial, Single-Dose Vial

Mumbai, Nov 15 (IEBusiness) Pharma Major, Lupin said that it 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 Co. Ltd.’s (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, company said in a filing with BSE.

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.

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

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