Glenmark receives ANDA approval for Regadenoson injection single-dose pre-filled syringe
The syringe is the generic version of Lexiscan1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US
Glenmark Pharmaceuticals has received tentative approval from the United States Food & Drug Administration (US FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US. According to IQVIATM sales data for the 12 months ending November 2021, the Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately $659.9 million.
Glenmark’s current portfolio consists of 172 products authorized for distribution in the US marketplace and 47 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.
