Dr. Reddy's Laboratories Ltd. launched Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan (Regadenoson) injection, approved by U.S. Food and Drug Administration (USFDA).
Lexiscan is a registered trademark of Astellas US LLC. It is an A2A adenosine receptor agonist that is a coronary vasodilator that is commonly used in pharmacologic stress testing. It produces hyperemia quickly and maintains it for a duration that is useful for radionuclide myocardial perfusion imaging.
Regadenoson was approved by the United States Food and Drug Administration on April 10, 2008, and is marketed by Astellas Pharma under the tradename Lexiscan. It is approved for use in the European Union and under the name of Rapiscan. It is marketed by GE Healthcare and is sold in both the United Kingdom and Germany. Regadenoson was approved for use in the European Union in September 2010.
Also USFDA completed a routine GMP inspection at our API manufacturing facility (CTO 1) in Bollaram, Hyderabad. The inspection was conducted from 1st May, 2023 to 5th May, 2023. The company has been issued a Form 483 with one observation.
