Glenmark Pharmaceuticals Inc announced that its US arm had received approval from the US’s health regulator Food and Drug Administration (FDA), for its Generic Regadenoson injection. Regadenoson injection is given during the preparation for a radiologic examination of blood flow via the heart to test for coronary artery disease. The approval given by the FDA to Glenmark Pharma is for Regadenoson Injection, 0.4 mg/5 mL Single-Dose Pre-Filled Syringe, the company said in a statement.
The company also said that the Lexiscan Injection, 0.4 mg/5 mL market achieved annual sales of approximately $659.9 million by November 2021. The company told its current portfolio includes 172 products authorized for distribution in the US marketplace and 47 abbreviated new drug applications (ANDAs) pending approval with the FDA.