Glenmark Pharma gets USFDA nod for prostate cancer treatment drug
Drug firm Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for Abiraterone Acetate tablets, used to treat prostate cancer. The approved product is a generic version of Zytiga tablets, 250 mg, of Janssen Biotech.
"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate tablets USP, 250 mg," the company said in a regulatory filing.
Quoting IQVIA sales data for the 12 month period ending August 2019, Glenmark said the Zytiga tablets, 250 mg market achieved annual sales of approximately $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.
Shares of Glenmark Pharma were trading 0.15 per cent higher at Rs 286.00 apiece on the BSE.