Abiraterone acetate is used to treat men with prostate cancer that has spread to other parts of the body.
New Delhi: Pharma and biotech major Wockhardt Ltd on Friday said it has received approval from the US health regulator for its generic prostate cancer tablet abiraterone acetate. The approval granted by the US Food & Drug Administration (USFDA) is for 250 mg tablet of abiraterone acetate, a generic version of Zytiga, marketed in the U.S. 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.
Prostate cancer is the development of cancer in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, some grow relatively quickly. The cancer cells may spread from the prostate to other areas of the body, particularly the bones and lymph nodes.
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.
Wockhardt Ltd. is a global pharmaceutical and biotechnology company headquartered in Mumbai, India. The company has manufacturing plants in India, UK, Ireland, France and the U.S. and subsidiaries in the US, UK, Ireland and France.