FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Glenmark’s Abiraterone Acetate Tablets Approved

Nov. 21, 2019

The FDA approved Glenmark Pharmaceuticals’ abiraterone acetate 250 mg as a generic of Janssen’s prostate cancer drug Zytiga (abiraterone).

Janssen earned approximately $794 million from sales of the Zytiga 250 mg for the 12-month period ending August 2019.

The approval brings Glenmark’s portfolio to 162 products authorized for distribution in the U.S., with 46 ANDA’s pending approval, the company said.

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