Glenmark Regadenoson Injection gets USFDA okay
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.
Read also: Glenmark Pharma arm secures USFDA nod for Ryaltris nasal spray
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.
Read also: Glenmark arm, Almirall ink pact to develop monoclonal antibody for autoimmune diseases
