Glenmark Pharma receives ANDA tentative approval for Regadenoson injection

Glenmark Pharmaceuticals Inc., USA has received tentative approval by 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 Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

Glenmark's current portfolio consists of 172 products authorized for distribution in the U.S. marketplace.

The company stated that it continues to identify and explore external development partnerships to accelerate the growth of its existing pipeline and portfolio.

The Lexiscan injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately $659.9 million, according to IQVIA sales data for the 12 month period ending November 2021.

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(With inputs from ANI)