Glenmark Pharmaceuticals receives ANDA approval for Abiraterone Acetate Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga Tablets, 250 mg, of Janssen Biotech, Inc. According to IQVIATM sales data for the 12 month period ending August 2019, the Zytiga Tablets, 250 mg market achieved annual sales of approximately $794.1 million. Glenmark’s current portfolio consists of 162 products authorized for distribution in the U.S. marketplace and 46 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 and portfolio.