Glenmark receives ANDA approval for Abiraterone Acetate tabs
The drug is the generic version of Zytiga Tablets, 500 mg, of Janssen Biotech
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga Tablets, 500 mg, of Janssen Biotech.
According to IQVIATM sales data for the 12 month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately $260.2 million.
Glenmark’s current portfolio consists of 173 products authorised for distribution in the US market place and 49 ANDA’s pending approval with the US 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.