Glenmark Pharma gets tentative USFDA nod for generic Regadenoson injection

Glenmark Pharmaceuticals announced on Monday that the country’s health regulator has given its generic Regadenoson injectable preliminary approval.

The regadenoson injection is given before a radiologic assessment of blood flow through the heart to check for coronary artery disease.

Glenmark Pharmaceuticals Inc, USA (Glenmark) received provisional clearance from the United States Food and Drug Administration (USFDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the company said in a statement. It’s the generic form of Astellas US Inc’s Lexiscan injection, 0.4 mg/5 mL (0.08 mg/mL), it said.

The Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market had annual sales of roughly USD 659.9 million, according to IQVIATM sales statistics for the 12 month period ending November 2021.

According to the business, its current portfolio includes 172 medications approved for distribution in the United States and 47 abbreviated new drug applications (ANDAs) awaiting FDA clearance.