Lupin gets USFDA nod for Decitabine- Myelodysplastic Syndrome drug

Mumbai: Pharma major Lupin has recently 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 (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. 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. Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells).

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