Glenmark receives ANDA approval for Fulvestrant Injection

August 26, 2019 | Monday | News

It is a generic version of Faslodex® Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL).

It is a generic version of Faslodex® Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.

According to IQVIATM sales data for the 12 month period ending June 2019, the Faslodex® Injection, 250 mg/5 mL (50 mg/mL) market2 achieved annual sales of approximately $549.9 million.

Glenmark’s current portfolio consists of 159 products authorized for distribution in the U.S. marketplace and 56 ANDA’s pending approval with the USFDA.