Glenmark Pharma gets USFDA approval for Abiraterone Acetate tablets USP, 250 mg

MUMBAI, Oct 17:Pharma major Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) 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 USD 794.1 million.
Glenmark’s current portfolio consists of 162 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the USFDA.
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.