Amphastar Pharmaceuticals, Inc. has received approval from the US Food and Drug Administration for its generic regadenoson injection 0.08mg/ml 5ml single dose pre-filled syringe. The agency has approved the firm’s abbreviated new drug application for the drug, determining that it is bioequivalent and therapeutically equivalent to Astellas Pharma’s branded regadenoson, Lexiscan.
Company CEO and president Jack Zhang confirmed that both the finished product and the active pharmaceutical ingredient will be produced in the US
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