FDA Approves Generic Dacogen (Decitabine for Injection)
Dr. Reddy's Laboratories announced that it has launched Decitabine for Injection 50mg, a generic therapeutic equivalent version of Dacogen (decitabine for Injection) following FDA approval of the company's ANDA for Decitabine for Injection.
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.
Decitabine 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.
Dacogen for Injection is available in 50mg single-use vials.
For more information call (908) 203-4900 or visit DrReddys.com.