![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Glenmark’s Abiraterone Acetate Tablets Approved
Glenmark’s Abiraterone Acetate Tablets Approved
![Grey Approved Stamp](https://www.fdanews.com/ext/resources/test/Drug-Images4/Grey_Approved_Stamp.gif?t=1576541258&width=430)
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.
Upcoming Events
-
21Oct