Glenmark Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe.

The drug is the generic version of Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US.

Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) had annual sales of around $659.9 million, as per IQVIA sales data for the 12-month period ending November 2021.

The current portfolio of Glenmark Pharmaceuticals includes 172 products authorized for distribution in the US along with 47 ANDA’s pending approval with the FDA.

  Astellas US, Glenmark Pharmaceuticals, Lexiscan Injection, Regadenoson Injection, US FDA, USA