Glenmark Pharmaceuticals Receives ANDA Approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)

/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final 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 Faslodex1 Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.

Glenmark Logo According to IQVIA 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 U.S. 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.

1All brand names and trademarks are the property of their respective owners.

2Market includes brand and all available therapeutic equivalents
*IQVIA National Sales Perspectives: Retail & Non-Retail, June 2019
About Glenmark Pharmaceuticals
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