Glenmark Pharma gets USFDA nod for prostate cancer treatment drug
- IBEF
- October 18, 2019
Glenmark Pharmaceuticals, a drug firm said it has received final approval for Abiraterone Acetate tablets from the US health regulator. These tablets are used in treatment of prostate cancer. The approved product is a generic version of Zytiga tablets, 250 mg, of Janssen Biotech.
According to the company in its regulatory filing, "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate tablets USP, 250 mg."
As per the sales data by IQVIA for the 12-month period that ended in August 2019, Glenmark said that the Zytiga tablets, 250 mg market has achieved an annual sale of approximately US$ 794.1 million.
Currently, Glenmark's portfolio has 162 products authorised for distribution in the US marketplace and 46 ANDA's pending approval with the USFDA.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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