Glenmark Pharma gets tentative FDA nod for generic Regadenoson injection

Glenmark Pharmaceuticals said its US arm has received tentative approval from the country's health regulator for its generic Regadenoson injection

Glenmark Pharmaceuticals on Monday said its US arm has received tentative approval from the country's health regulator for its generic Regadenoson injection.

Regadenoson injection is given during the preparation for a radiologic examination of blood flow through the heart to test for coronary artery disease.

The tentative approval granted by the United States Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the company said in a statement.

It is the generic version of Lexiscan injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US Inc, it added.

Citing IQVIATM sales data for the 12 month period ending November 2021, the company said the Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately USD 659.9 million.

The company said its current portfolio consists of 172 products authorized for distribution in the US marketplace and 47 abbreviated new drug applications (ANDAs) pending approval with the USFDA.