Glenmark Pharmaceuticals receives sANDA approval for Abiraterone Acetate Tablets USP, 500 mg


Mumbai : Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga®1 Tablets, 500 mg, of Janssen Biotech Inc. According to IQVIATM sales data for the 12 month period ending March 2022, the Zytiga® Tablets, 500 mg market2 achieved annual sales of approximately $260.2 million. Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 ANDA’s pending approval with the U.S. 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.

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