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Amphastar Receives FDA Approval For Regadenoson Following Solid Q1

Multiple Pipeline Launches Expected For H2

 
• By Chloe Kent

Amphastar has become the fifth firm to receive FDA approval for generic regadenoson, but the exact launch date for the firm and its other generic competitors remains uncertain.

Ariel view of gas pipeline
Amphastar expects to launch at least two new generics this year • Source: Shutterstock

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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