Glenmark Pharmaceuticals receives tentative ANDA approval for Abiraterone Acetate Tablets USP, 250 mg

Deepthi | Myequity news | Date : 23-01-2019 11:05:00 IST

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

According to IQVIATM sales data for the 12 month period ending November 2018, the Zytiga® Tablets, 250 mg market2 achieved annual sales of approximately $1.3 billion*.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.

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