InnoPharma has announced that it has received approval from the Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Decitabine for Injection, a generic version of Eisai’s Dacogen.

Dacogen is a nucleoside metabolic inhibitor indicated for 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. It is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation or apoptosis.

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Decitabine for Injection will be available in 20mg single-dose vials containing 50mg Decitabine.

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