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23-Jan2019

Glenmark gets tentative ANDA approval for Abiraterone Acetate Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga Tablets, 250 mg, of Janssen Biotech, Inc.  

According to IQVIA 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 authorized for distribution in the US marketplace and 54 ANDA's pending approval with the USFDA. 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.  

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).


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