USFDA nod to Wockhardt's drug for prostrate cancer

Pharma and biotech major Wockhardt Ltd on Friday said it has received approval from the US health regulator for its generic prostrate cancer tablet abiraterone acetate. The approval granted by the US Food & Drug Administration (USFDA) is for 250mg tablet of abiraterone acetate, a generic version of Zytiga, marketed in the US and other countries by Johnson & Johnson, the company said in a statement.

Abiraterone is used to treat men with prostate cancer that has spread to other parts of the body, it added. Commenting on the approval, Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said, "This is one more product in Wockhardt's growing portfolio of oncology products in the US and has several pending ANDA's for oncology products."

He further said, "Along with oncology products, speciality products remain a focus area for our US business and for creating a sustainable growth worldwide." Wockhardt will be launching the product in the US in a short period of time and is being manufactured at a contract manufacturing facility, based near Hyderabad.