Wockhardt gets US FDA nod for Decitabine injection

Pharma major Wockhardt Wednesday said it has received approval from the US health regulator for its 50 mg injection of Decitabine which is used to treat certain forms of cancer.

"Wockhardt has received approval from the United States Food and Drug Administration (US FDA) for an ANDA (abbreviated new drug application) for 50 mg injection of Decitabine, which is used to treat certain forms of cancer," the company said in a filing to the BSE.

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 data, the product has sales of $120 million in the US.

"This is the third US FDA approval for an oncology product for Wockhardt during the past three months, and has added to our growing portfolio of cancer drugs," Wockhardt Group founder Chairman Habil Khorakiwala said.

"Wockhardt has been sustaining growth in the US and worldwide through an increasing portfolio of specialty products including oncology drugs," he said.

Wockhardt will launch this product in the US in a short period of time.

With its nationwide distribution network and its relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market, the company said.

The product is being manufactured at a contract manufacturing facility, based near Hyderabad.