Lupin gets USFDA nod for blood treatment drug

Pharmaceutical manufacturer Lupin said it received approval from the US FDA for launching Decitabine injection for treating conditions caused by defective blood cells, known as myelodysplastic syndromes.

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

The drug is the generic equivalent of Otsuka Pharmaceutical Co. Ltd.’s Dacogen.

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 and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

The subtypes that can be treated with the drug include refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.

Lupin is one of the world’s biggest makers of generic drugs, and sells both branded & generic formulations, biotechnology products and pharmaceutical ingredients globally.

It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.