Glenmark Pharmaceuticals receives sANDA approval for Abiraterone Acetate Tablets

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Glenmark Pharmaceuticals, today, announced that they have received final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 500 mg. 

Abiraterone Acetate Tablets are the generic version of Janssen Biotech’s Zytiga®1 Tablets, 500 mg. According to WebMD, ‘This medication is used to treat prostate cancer. Abiraterone belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Abiraterone works by blocking the production of testosterone, thereby slowing the growth and spread of prostate cancer.’

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 existing portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 ANDA’s pending approval with the U.S. FDA. The pharma firm is on its way to identifying and exploring external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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