Thursday, 14 November 2019

Glenmark receives ANDA approval for Abiraterone Acetate Tablets USP, 250 mg

18 October 2019 | News

It is a generic version of Zytiga®Tablets, 250 mg, of Janssen Biotech, Inc.

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration 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 market2 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.

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