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Glenmark gets tentative nod from USFDA to market prostate cancer drug

The approved product is a generic version of Janssen Biotech Inc's Zytiga tablets

Usfda  |  Prostate Cancer  |  Glenmark Pharmaceuticals

Press Trust of India  |  New Delhi 

Photo: iStock

has received tentative nod from the US health regulator for Abiraterone Acetate tablets, used in the treatment of

Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets USP in the strength of 250 mg, the company said in a BSE filing on Wednesday.

The approved product is a generic version of Janssen Biotech Inc's Zytiga tablets.

Quoting IQVIA sales data for the 12-month period ended November 2018, said, Zytiga tablets 250 mg market achieved annual sales of approximately $1.3 billion.

The company's current portfolio consists of 148 products authorised for distribution in the US market and 54 abbreviated new drug applications (ANDAs) pending approval with the

Shares of Glenmark Pharmaceuticals were trading 1.17 per cent lower at Rs 648.45 apiece on the BSE.

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First Published: Wed, January 23 2019. 11:30 IST