FDA clears Wockhardt’s generic Zytiga

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FDA clears Wockhardt’s generic Zytiga

By Sandra Levy - 03/06/2019
Wockhardt has received Food and Drug Administration approval for its generic Zytiga (abiraterone acetate tablets). The company's generic of Janssen's branded drug was approved in 250-mg dosage strength.

The generic Zytiga is indicated to treat men with prostate cancer that has spread to other parts of the body.

The product has a market value of $1.26 billion, according to IQVIA December 2018 data.

“This is one more product in Wockhardt’s growing portfolio of oncology products in the U.S. and has several pending ANDA’s for oncology products,” Wockhardt founder, chairman and group CEO Habil Khorakiwala, said. “Along with oncology products, specialty products remain a focus area for our U.S. business and for creating a sustainable growth worldwide.”

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