Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 50mg injection of Decitabine, which is used to treat certain forms of cancer. Wockhardt’s Decitabine Injection is a generic version of Dacogen, marketed in USA and other countries by Otsuka.
Decitabine is used to treat Myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells.
According to IQVIA February 2019 data, the product has sales of $120 million in the US.
The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India.