Express Pharma

Glenmark Pharma receives tentative ANDA approval for prostate cancer drug

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The drug is a generic version of Zytiga1 Tablets, 250 mg, of Janssen Biotech

Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (US FDA) for Abiraterone Acetate Tablets USP, 250 mg, for the treatment of prostate cancer. The drug is a generic version of Zytiga1 Tablets, 250 mg, of Janssen Biotech.

According to IQVIATM, sales data for the 12 month period ending November 2018, the Zytiga Tablets, 250 mg market achieved annual sales of approximately $1.3 billion.

Glenmark’s current portfolio consists of 148 products authorised for distribution in the US marketplace and 54 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.

 

 

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