MUMBAI:
Pharmaceutical and biotechnology major Wockhardt received an approval from the US Food and Drug Administration (USFDA) for its generic drug to treat prostate cancer, that is being manufactured in India.
The approval was for the 250 mg tablet of Abiraterone acetate, which is used for men with prostate cancer that has spread to other parts of the body. “This is one more product in Wockhardt’s growing portfolio of oncology products in the US and has several pending ANDA (Abbreviated New Drug Application) for oncology products,” Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO, said in a statement.
“Along with oncology products, specialty products remain a focus area for our US business and for creating a sustainable growth worldwide,” he added. Wockhardt’s Abiraterone acetate tablet is a generic version of Zytiga, marketed in the US and other countries by Johnson and Johnson.
The product, which is manufactured at a contract manufacturing facility, based near Hyderabad, will be launched in the US soon, the statement noted.
