Glenmark Pharma bags USFDA nod for prostate cancer drug Abiraterone Acetate

Prostate cancer is a disease in which malignant (cancer) cells form in the tissues of the prostate.

Published On 2022-05-20 06:45 GMT   |   Update On 2022-05-20 06:45 GMT
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Mumbai: Drugmaker, Glenmark Pharmaceuticals Inc., USA has announced that the company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 500 mg used for the treatment of prostate cancer.

The product is a generic version of Zytiga Tablets, 500 mg, of Janssen Biotech Inc.

Prostate cancer is a disease in which malignant (cancer) cells form in the tissues of the prostate. It is most common in older men. The prostate is a gland in the male reproductive system. It lies just below the bladder (the organ that collects and empties urine) and in front of the rectum (the lower part of the intestine).

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According to IQVIA 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 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.

Read also: Glenmark Pharma bags USFDA nod for generic version of Enstilar Foam

Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

Read also: Glenmark gets CDSCO panel nod for Phase 4 study of anti-diabetic FDC drug

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