Glenmark Pharmaceuticals gets FDA approval for Lexiscan Injection generic

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.