www.fdanews.com/articles/193522-glenmarks-abiraterone-acetate-tablets-approved
Glenmark’s Abiraterone Acetate Tablets Approved
November 20, 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.