Glenmark Pharma receives tentative approval for regadenoson injection

Glenmark Pharmaceuticals on Monday announced that it has received tentative approval from the United States Food & Drug Administration for regadenoson injection.

Regadenoson injection is the generic version of Lexiscan Injection of Astellas US, Inc. According to IQVIA sales data for the 12-month period ending November 2021, the Lexiscan Injection market achieved annual sales of approximately $659.9 million.

Regadenoson is used to test the heart for coronary artery disease. It is used in patients who cannot exercise for their stress test.

Glenmark's current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 47 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark said it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries. The drug company posted a 10.1% increase in consolidated net profit to Rs 257.66 crore on a 7.5% rise in net sales to Rs 3,125.43 crore in Q2 FY22 over Q2 FY21.

Shares of Glenmark Pharmaceuticals were trading 0.16% higher at Rs 516.80 on BSE.

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