Glenmark Pharmaceuticals receives tentative ANDA approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)
Deepthi | Myequity news | Date : 07-02-2019 10:15:00 IST
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL), a generic version of FASLODEX®1 Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.
According to IQVIATM sales data for the 12 month period ending December 2018, the FASLODEX® Injection, 250 mg/5 mL (50 mg/mL) market2 achieved annual sales of approximately $533.3 million.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical organization. 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.