MSN Labs to Launch Generic Version of Zytiga in U.S. Following FDA Approval

MSN Labs to Launch Generic Version of Zytiga in U.S. Following FDA Approval
MSN Labs, the parent company of Novadoz Pharmaceuticals, is launching a generic version of Janssen Pharmaceuticals’ approved therapy Zytiga (abiraterone acetate) in the U.S. market. Following its approval by the U.S. Food and Drug Administration (FDA), the generic abiraterone acetate 250mg tablets will be available for the treatment of men with metastatic castration-resistant prostate cancer (CRPC). This new generic product will be sold in 120 tablet-count bottles, and is recommended in combination with a steroid medication like prednisone or methylprednisolone. “The approval of generic abiraterone is ... significant for our organization as it continues to fill our portfolio with important products, most specifically those used in the oncology class,” Seshu Akula, president of North America generics at Novadoz, said in a press release. "These products offer great value to patients and our customers, and continue to build on Novadoz's successful entrance in the U.S market," he added. Therapies that lower male sex hormones — required for prostate cancer to survive and grow — are a mainstay of therapy for advanced prostate cancer. However, most men will acquire resistance to such approaches. This often happens because the receptor for these hormones, called the androgen receptor, becomes constantly active, even in the absence of androgens. In such cases, the cancer is called castration-resistant. Therapies that inhibit, or block the androgen receptor — such as Pfizer and Astellas‘ Xtandi and Janssen's Zytiga — have largely improved the overall survival of prostate cancer patients. Those treatments are now approved for mCRPC patients in the U.S. and Europe. Zytiga – and, by extension, the generic abiraterone acetate version – w
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