FDA Approves Generic Abiraterone

MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals' product Zytiga©, on July 9th. This FDA approval marks the ninth since March 2018, when Novadoz began commercial operations as MSN Labs' U.S sales and marketing affiliate for their finished dosage forms.

MSN's approval for Abiraterone Acetate 250mg tablets, in the class of oncology drugs indicated for the treatment of prostate cancer when used with a steroid medication (prednisone or methylprednisolone). The product is available in 120 tablet count bottles. This is the second oncology product launched by Novadoz, the first Capecitabine 150mg & 500mg tablets, their generic version of Novartis' Xeloda©, indicated for the treatment of breast cancer. Abiraterone Acetate 250mg tablets are currently trending over $997MIL in brand and generics sales, as well as an approximate 9% increase in prescriptions since 2016 according to published reports.

"The approval of generic Abiraterone is a 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, N.A Generics – Novadoz Pharmaceuticals, said. "These products offer great value to patients and our customers, and continue to build on Novadoz's successful entrance in the U.S market. We are continuing to focus on our plans to launch 10 to 12 additional products in the next 12 to 18 months."

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