Glenmark Regadenoson Injection gets USFDA okay

Published On 2022-01-17 05:55 GMT | Update On 2022-01-17 05:55 GMT

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Mumbai: Drug maker, Glenmark Pharmaceuticals Inc., USA has received tentative approval by the United States Food & Drug Administration (USFDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe.

The product is a generic version of Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

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

According to IQVIA sales data for the 12 month period ending November 2021, the Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately $659.9 million.

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 continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries.

Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Glenmark Regadenoson Injection gets USFDA okay

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