Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 250mg tablet of Abiraterone acetate, which is used to treat Prostate Cancer. Wockhardt’s Abiraterone acetate tablet is a generic version of Zytiga®, marketed in USA and other countries by Johnson & Johnson.
Abiraterone is used to treat men with prostate cancer that has spread to other parts of the body. According to IQVIA December 2018 data, the product has sales of $1.26 billion in the US.
“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” said Dr. Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO. “Along with oncology products, specialty products remain a focus area for our US business and for creating a sustainable growth worldwide” he said.
Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market.
The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India.