Glenmark receives tentative ANDA approval for Fulvestrant
07 February 2019 | News
It is a generic version of FASLODEX Injection
Glenmark Pharmaceuticals 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 Injection, 250 mg/5 mL (50mg/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.
Glenmark’s current portfolio consists of 148 products authorized for distribution in the U.S. marketplace and 54 ANDA’s pending approval with the U.S. FDA.
