According to a statement, the tentative approval was granted by the United States Food & Drug Administration to Glenmark Pharmaceuticals Inc., USA (Glenmark).
It is for Regadenoson Injection at 0.4 mg/5 mL (0.08 mL) Single-Dose Prefilled Syringe. It is the generic Lexiscan injection at 0.4 mg/5mL (0.08 mg/mL) of Astellas US Inc.
The company cited IQVIATM sales data from the 12-month period ending November 2021 and stated that the Lexiscan(r), 0.4 mg/5 mL (0.08mg/mL) market had achieved an annual sales figure of around USD 659.9 millions.
According to the company, its current portfolio includes 172 products that are authorized for distribution in the US market and 47 abbreviated drug applications (ANDAs), which are awaiting approval by the USFDA.