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Glenmark Pharma gets final USFDA nod for generic version of Abiraterone Acetate tabs

The approval granted by the US Food and Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for Abiraterone Acetate tablets of strength 500 mg, the company said in a statement.It is the generic version of Zytiga tablets, 500 mg, of Janssen Biotech Inc, it added.

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Glenmark said its current portfolio consists of 173 products authorised for distribution in the US marketplace and 49 abbreviated new drug applications pending approval with the USFDA.

Glenmark Pharmaceuticals Ltd on Friday said its US arm has received final approval from the US health regulator for its generic version of Abiraterone Acetate tablets used for the treatment of prostate cancer.

The approval granted by the US Food and Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for Abiraterone Acetate tablets of strength 500 mg, the company said in a statement. It is the generic version of Zytiga tablets, 500 mg, of Janssen Biotech Inc, it added.

Citing IQVIA sales data for the 12 month period ended March 2022, the company said Zytiga tablets 500 mg achieved annual sales of approximately USD 260.2 million.

Glenmark said its current portfolio consists of 173 products authorised for distribution in the US marketplace and 49 abbreviated new drug applications pending approval with the USFDA.

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