Wockhardt gets USFDA approval for prostate cancer drug

Wockhardt Limited has received approval from the United States Food & Drug Administration (USFDA) for an ANDA for 250 mg tablet of Abiraterone acetate, which is used to treat prostate cancer.

Wockhardt's Abiraterone acetate tablet is a generic version of Zytiga, marketed in the US and other countries by Johnson & Johnson. Abiraterone is used to treat men with prostate cancer that has spread to other parts of the body. The product has sales of US$1.26 billion in the US.

This product will add up to the company’s portfolio of oncology products in the US and still has several pending ANDA’s for oncology products. According to the company, its focus area for the US business continues to be on speciality products.

The company will be soon launching the product in the US market. The drug is being manufactured at a contract facility, based near Hyderabad, India.

Wockhardt is a Global Pharmaceutical and Biotech company having a presence in the US, the UK, Ireland, Switzerland, France, Mexico, Russia and many other countries.

On Friday, the stock of Wockhardt opened at Rs. 401.75 per share. It jumped by 7.6 per cent and made intra-day high of Rs. 426.30 from its previous close of Rs. 396.05.