Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Regadenoson injection, 0.08 mg/mL, 5mL Single Dose Pre-Filled Syringe. Regadenoson is indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. The FDA determined that Amphastar’s regadenoson is bioequivalent and therapeutically equivalent to Astellas Pharma U.S., Inc’s Lexiscan (Regadenoson Injection).
Amphastar’s CEO and President, Dr. Jack Zhang, commented: “We are excited with the FDA’s approval of our Regadenoson injection as this broadens our portfolio of products, highlighting our capabilities in combination product development, while providing patients and healthcare providers with another important option. Both the finished product and Active Pharmaceutical Ingredient (API) will be manufactured in the United States.”
According to IQVIA, the U.S. sales for Astellas’ Lexiscan (Regadenoson Injection) were approximately $650 million for the 12 months that ended March 31, 2022.
The timing of commercialization of Amphastar’s regadenoson product is subject to the confidential settlement terms agreed to between the Company, and Astellas US LLC.