Glenmark receives ANDA approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)

A generic version of Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals

Glenmark Pharmaceuticals , USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL), a generic version of Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals.

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

Glenmark’s current portfolio consists of 159 products authorised for distribution in the US marketplace and 56 ANDA’s pending approval with the US FDA. 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.