ALPMY - Amphastar announces FDA approval of generic for Astellas' Lexiscan

Generic drugmaker Amphastar Pharmaceuticals (NASDAQ:AMPH) announced on Monday that the FDA approved its Abbreviated New Drug Application ("ANDA") for Regadenoson, a bioequivalent and therapeutically equivalent to Lexiscan developed by Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY). Regadenoson injection is indicated as a 0.08 mg/mL, 5mL single-dose prefilled syringe for radionuclide myocardial perfusion imaging in those unable to undergo adequate exercise stress, Amphastar (AMPH) said. According to healthcare analytics company IQVIA (IQV), Lexiscan generated nearly $650 million in sales for the 12 months ending Mar. 31. The timeline for the commercialization of Regadenoson depends on the terms of an agreement between Amphastar (AMPH) and Astellas (OTCPK:ALPMF). Read: In April, Amphastar (AMPH) announced the FDA approval of a generic to Organon Pharma’s (OGN) Ganirelix Acetate Injection.

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Amphastar announces FDA approval of generic for Astellas’ Lexiscan