Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

Glenmark Pharmaceuticals 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.

New Delhi: Glenmark Pharmaceuticals has received the tentative nod from the US health regulator for Abiraterone Acetate tablets, used in the treatment of prostate cancer.

Glenmark Pharmaceuticals 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.

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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, Glenmark Pharmaceuticals said, Zytiga tablets 250 mg market achieved annual sales of approximately USD 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 USFDA.

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