Glenmark receives sANDA approval for Abiraterone Acetate tablets

Glenmark receives sANDA approval for Abiraterone Acetate tablets

By: IPP Bureau

Last updated : May 20, 2022 12:18 pm



According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million


Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate tablets USP, 500 mg, the generic version of Zytiga1 tablets, 500 mg, of Janssen Biotech Inc.

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million.

Glenmark's current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline.

Glenmark Pharmaceuticals USFDA Zytiga

First Published : May 20, 2022 12:00 am